Austrian basketball league players Michael Fraser and Kevin Nelson have been banned for seven months for doping, the league said Wednesday.
Fraser, a Canadian playing for the Fuerstenfeld Panthers, and Nelson, a U.S. citizen on the Kapfenberg Bulls team, are also required to reimburse the cost of their doping tests, the league said in a …
Attorney Michael Shakman asked a federal judge Monday to appoint amonitor to oversee all hiring in Cook County government -- just asthe judge has done for the city of Chicago.
Shakman's motion is based on two Chicago Sun-Times investigativereports about patronage hiring in Cook County government.
Shakman is the attorney who filed the 1969 lawsuit that forced thecity, county and other local governments to forbid hiring and firingbased on political clout. But as the Sun-Times stories have shown andas Shakman's motion alleges, patronage hiring has become rampant incounty government again.
"It has become clear that . . . Cook County has engaged insubstantial, …
Unlike many strip shredders for paper which require a two-step process for cross-cut consistency, the ReTech RG52P rotary grinder performs that process in one pass. …
British consumers opted to pay off debts rather than go on a pre-Christmas spending spree, the banking industry's main lobby group said Monday, in another sign of the difficult retailing climate.
In its monthly assessment of lending conditions, the British Bankers' Association said the amount of money outstanding on credit cards dropped by 218 million pounds in December, while bank customers continued to pay off more of their overdrafts and personal loans than they took on. Total outstanding borrowing dropped by another 135 million pounds ($301 million), the fifth straight monthly fall.
"Consumer credit was very weak in December as people reined in …
Dale Petroskey, the president of the Baseball Hall of Fame, wasn'ttaking calls Thursday, and I can't say that I blame him.
It's one thing to call critics of the war in Iraq unpatriotic; youcan hardly get in trouble doing that these days. But mess around withBull Durham"? Try to cast a screening of one of the top baseballmovies of recent years as giving aid and comfort to the enemy?
Good grief, man, I know these are troubled times and we're allunder a lot of pressure, but get a grip. I mean, they're going to letPete Rose into the Hall of Fame and kick Crash Davis out?
Move over, Hootie," said Ron Shelton, the writer-director of BullDurham," on the phone from Los …
Seth "Hot Dog" Bailey
Seth "Hot Dog" Bailey, 78, of Baker's Fork Rd., Charleston, diedSaturday, July 3, 2004, at home after a short illness.
He was born July 17, 1925, to Issac Christopher and CassieCanterbury Bailey in Oceana, W.Va. Mr. Bailey was retired from PughFurniture and Meadowbrook Golf Course.
He is survived by his wife, Bessie Louise Skiles Bailey;daughters, Sussion Harper and husband, Gary, and Betty Jo Olive andhusband, Steve; sons, John Oliver and wife, Iona, William Ernest"Bill" Bailey, Arthur C. "Jake" Stover; foster son, Clarence Skilesand wife, Debbie; brothers-in-law, Emory J. Skiles, and Martin I.Skiles; special friend, John Monk; 17 …
The widow of poisoned Kremlin foe Alexander Litvinenko held an emotional conversation Saturday with a former KGB agent who says he warned her husband about a Russian government plot to kill him.
Marina Litvinenko, 44, broke down in tears as she spoke with Mikhail Trepashkin by phone a day after the former agent was released from jail.
Trepashkin has said he was asked in 2002 to join a group of Russian intelligence agents targeting Boris Berezovsky, a self-exiled Russian tycoon living in London, and Litvinenko. He said he warned Litvinenko about the alleged death squad.
After the phone call, Marina Litvinenko told The Associated Press that …
Brownlee, John (Donald Mackensie), Australian baritone; b. Geelong, Jan. 7, 1900; d. N.Y., Jan. 10, 1969. He was a pupil of Gilly in Paris, where he made his operatic debut as Nilakantha in Lakmé at the Théâtre-Lyrique in 1926. On June 8, 1926, he first appeared at London's Covent Garden as Marcello during Melba's farewell concert. From 1927 to 1936 he was a member of the Paris Opéra; also sang at the Teatro Colón in Buenos Aires (1931) and the Glyndebourne Festivals (1935–39). On Feb. 17, 1937, he made his Metropolitan Opera debut in …
PERFORMANCE
Valley favorite returns as this weekend's soloist
As Boise Philharmonic fans well know by now, typifying the traditional image of a stuffy orchestral soloist isn't among pianist Alpin Hong's talents.
He'd rather rock out.
This weekend. Hong takes the stage with Boise Philharmonic for the second time, after quickly earning the adoration of symphony fans young and, ahem ... younger, with his first Philharmonic appearance in 2007.
Known for his verve, charisma and spunky way with the ivories, Hong is the sort of keystone musician to whom orchestral music owes an increasing debt. Pictured at alpinhong.com with his snowboard, skateboard, video …
A judge on Friday awarded $4,510 (euro2,858.05) in damages to a photographer who worried he would be killed when Zsa Zsa Gabor's husband punched him in the face on a Beverly Hills street.
The eccentric hubby, Frederic Von Anhalt, initially wanted to give the man much more for busting open his lip.
In his complaint, Dirk Smeten claimed Frederic Von Anhalt, 62, angrily approached and began punching him repeatedly while Smeten attempted to photograph him in May 2005. The blows caused Smeten to fall to the sidewalk, according to the complaint.
Smeten claimed he suffered lip lacerations, cuts to his face, swelling, pain, high blood pressure, headaches …
A New easy access bus service has been launched for wheelchairusers in the North-east.
Bus operators Stagecoach Bluebird have unveiled 10 new easyACCESSEnviro 300 buses for its Aberdeen to Inverurie 307 route.
The new buses will also stop at Bucksburn, Blackburn and Kintore.
They have been designed to make it easy …
Pavilions of Plenty: Exhibiting American Culture Abroad in the 1950s. By Robert H. Haddow Washington, D.C.: Smithsonian Institution Press, 1998. x + 260 pp. Bibliographical references, notes, and index. $37.50. ISBN 1560987057.
Reviewed by Jacqueline McGlade
In Pavilions of Plenty, art historian Robert H. Haddow chronicles the transformation of government-sponsored trade fairs and exhibitions from cultural exchanges to propaganda weapons during the early years of the Cold War. According to Haddow, trade fairs became the vehicles most favored by government administrators and business supporters to counter communism through the promotion and transplantation of democratic …
Former President Vaclav Havel has finished shooting his first and probably last film.
Havel spokeswoman Ivana Reichlova says the former dissident playwright and post-communist Czechoslovakia's first president finished on-location camera work on the film on Saturday.
The film is a cinematic version of "Leaving," a Havel play that was staged two years ago. His actress wife, Dagmar, plays the leading female role.
The daily Mlada Fronta Dnes on Monday quoted Havel as saying the film will probably also be his last one.
These are among the latest cases to be dealt with by BathMagistrates' Court.
Carla Phippen, 22, of St Michael's Road, Whiteway, was given a 20-week prison sentence for four counts of assaulting a police officerand using threatening or abusive words or behaviour.
Jane Ellis, 38, of Timsbury Road, Farmborough, was fined Pounds60 and given three penalty points for speeding. Nikita Howard, 24,of Roundhill Park, Bath, was given a community order, a curfew andan electronic tag for possession of cocaine and diamorphine.
Jacqueline Taylor, 41, of Sheridan Road, Bath, was fined Pounds65 for using threatening or abusive words or behaviour.
Charles Byrd, 56, of Mortimer Close, Bath, was fined Pounds 60and given three penalty points for driving through a red light.
Michael Hall, 21, of Hinton Villas, Hinton Charterhouse, wasfined Pounds 65 and given six penalty points for driving otherwisethan in accordance with a licence, driving without insurance anddriving without a test certificate.
Paula Tucker, 48, of Brooklyn Road, Bath, was fined Pounds 130and disqualified from driving for six months for two counts ofspeeding.
Claire Kite, 28, of Blenheim Close, Peasedown St John, was givena one-year conditional discharge and ordered to pay Pounds 4.30compensation for shoplifting.
Richard Marwood, 23, of Haycombe Drive, Bath, was given acommunity order and ordered to pay Pounds 250 compensation for usingthreatening or abusive words or behaviour and criminal damage.
Ann James, 63, of Woodborough Hill, Peasedown St John, was finedPounds 525 and given six penalty points for failing to provide adriver's identity to the police.
Steven Richard Smith, 34, of Upper Weston, was given a 16-weeksentence suspended for 12 months, an unpaid work requirement andordered to pay Pounds 617.18 compensation for assault by beating andtwo counts of criminal damage.
Mark Coles, 24, of Aubrey Meads, Bitton, was fined Pounds 100 andgiven three penalty points for speeding.
Wendy Howell, 53, of The Oval, Bath, was given a 12-monthconditional discharge for shoplifting. James Archer, 30, ofStirtingale Road, Bath, was fined Pounds 60 and given three penaltypoints for speeding.
Glyn Webb, 40, of Ivy Avenue, Oldfield Park, was given acommunity order and ordered to pay Pounds 100 compensation for twocounts of assault by beating.
Phillip Cowley, 49, of Quantocks, Foxhill, was given a six-monthconditional discharge for shoplifting. Bradley Skipp, 21, ofHaycombe Drive, Bath, was given a community order and ordered to payPounds 150 compensation for two counts of assault by beating.
Christine White, 55, of Rosewarn Close, was given a communityorder for shoplifting while under a conditional discharge.
PHILADELPHIA--An amateur genealogist wants to create a way forpeople to find out whether they're descended from Benjamin Franklinand he needs some DNA to do it. One possibility, of course, would bedigging up Franklin's bones, which have been buried for 212 yearsnear Independence Hall. Since that seems unlikely, L. David Roper isfocusing instead on men with well-documented ties to the statesmanand inventor.
Roper says all he needs from the candidates is a simple, $150analysis of their Y chromosomes--genetic material handed down fromfathers to sons.
Y chromosomes change infrequently from generation to generation.Even after two centuries, males related to Franklin would have nearlyidentical ones, Roper said.
"This is as close as we can get to Benjamin's DNA without exhuminghim or finding one of his teeth," said Roper, a retired Virginia Techphysics professor who lives in Blacksburg, Va.
Roper said he doesn't know of any practical use for his research,though it could smash or support a bit of family mythology. Hismother is a Franklin and he plans to test himself.
In the decades after his death, rumors flew that Franklin, aprinter and philosopher who persuaded France to enter theRevolutionary War and helped craft the Constitution, may havefathered several children out of wedlock.
"I got a call from a guy who thinks he is descended from anillegitimate son of Benjamin's," Roper said. "Who knows? Maybe it'strue. This would tell us."
A similar DNA test showed Thomas Jefferson was related to thechild of one of his slaves, Sally Hemings. Donors would have to paythe $150 fee, which would go to the lab for the testing.
DNA sampling is painless, requiring only a few cells swabbed frominside of the cheek, but it does have limitations, said Dr. ScottWoodward, a Brigham Young University professor and expert onmolecular genealogy.
Y chromosomes can tell only whether someone is related to anotherperson, not whether they are directly descended from them, he said.The tests also don't work for women, who have no Y chromosome andwhose X chromosomes change more frequently from generation togeneration.
Roper has already received DNA samples from several possibleFranklin relatives, most of whom share a similar pattern of Ychromosome markers. He is still working on estimating the most likelysequence for the founding father himself.
In the meantime, Roper said he'll also continue looking forsomething that might have Franklin's actual DNA in it--like a tooththat might have been pulled by a dentist, then hidden away.
"We were thinking about placing an advertisement in a dentaljournal, trying to see if someone held on to a souvenir, centuriesago," he said.
AP
South Korea's exports rose to a record high in 2007, though the country posted its first trade deficit in nearly five years in December because of costlier raw materials, the government said Wednesday.
Exports rose 14.2 percent in 2007 to US$371.8 billion (euro254.6 billion), while imports increased 15.3 percent to US$356.7 billion (euro244.2 billion), the Ministry of Commerce, Industry and Energy said in a report.
That resulted in a trade surplus of US$15.1 billion (euro10.3 billion) for the year, the ministry said.
South Korea posted a trade deficit of US$865 million (euro592 million) in December, however, due to higher international resource prices and a recovery in domestic consumption, the ministry said. It was the first monthly trade shortfall since March 2003.
Exports in December rose 15.5 percent from the same month in 2006 to total US$33.25 billion (euro22.76 billion), the report said. Imports increased 24 percent to US$34.11 billion (euro23.35 billion).
The data are preliminary.
NEW YORK (AP) — Julio Teheran earned his first big league win as the Atlanta Braves used a lineup with Chipper Jones as the No. 2 hitter for the first time in 15 years to beat the New York Mets 5-1 Thursday and complete a sweep of a doubleheader made necessary by the threat of Hurricane Irene.
Jones had a sacrifice fly and RBI double in the nightcap and a solo homer and a double in the opener, a 6-5 victory for Atlanta. The Braves were making a quick stop in New York to play two games postponed Aug. 27-28 after being handed their first three-game sweep of the season, by the Phillies.
The Braves next head to St. Louis for a crucial series with the team they lead in the wild-card race by 7½ games. Only several hundred fans were on hand to see the start of the twinbill at 4:10 p.m. A few thousand more sat through a misty rain in the nightcap, though the announced attendance was 25,953.
| Dodgers 7, Nationals 4 |
|---|
At Washington, Tony Gwynn hit a tiebreaking double in the ninth inning as Los Angeles beat Washington in the first game of a doubleheader on Thursday.
Gwynn drove in Jerry Sands and Rod Barajas with a long double to center off Drew Storen (6-3). Dee Gordon added a run-scoring single — setting a career high with his fourth hit of the game.
Mike MacDougal (3-1), the Dodgers' sixth pitcher, worked a scoreless eighth for the win. Javy Guerra pitched the ninth for his 16th save. Six Los Angeles relievers held Washington hitless over the last 6 1-3 innings.
The second game of the doubleheader was later rained out.
| Phillies 7, Brewers 2 |
|---|
At Milwaukee, Cole Hamels pitched a four-hitter and Hunter Pence's triple keyed a six-run sixth inning as Philadelphia beat Milwaukee.
Hamels (14-7) gave up solo home runs to Yuniesky Betancourt and Corey Hart, but kept Milwaukee from mounting any big innings in a game between two best teams in the National League.
The Phillies managed only one hit off Chris Narveson (10-7) the first 5 2-3 innings, but then broke through for six runs by getting seven consecutive batters on base to chase the Milwaukee starter in the sixth. Philadelphia had 11 of its 12 hits in the final 3 1-3 innings to win its fourth straight.
Pence also had a run-scoring double in the ninth and finished with three RBIs.
| Diamondbacks 4, Padres 1 |
|---|
At Phoenix, Ian Kennedy struck out a season-high 11 batters over seven-plus innings for his National League-leading 19th win as Arizona beat San Diego.
Kennedy (19-4) scattered seven hits and did not walk a batter over 7 2-3 innings. The right-hander joined Detroit's Justin Verlander and New York Yankees ace C.C. Sabathia as the majors' only 19-game winners.
J.J. Putz pitched the ninth for his 38th save.
Justin Upton hit his career-best 29th home run for the Diamondbacks, who won for the 14th time in 16 games to open a 7½-game lead over San Francisco in the NL West.
Corey Luebke (5-9) allowed two runs and three hits over 5 2-3 innings. He walked four and struck out nine.
Thornwood has had one of the state's dominant softball teams thelast six years. But the prize of a state title, which has only cometo the Chicago area once since 1976 (Morton won in 1986), has eludedthe Thunderbirds.
This year, they have the key ingredients to take that extrastep.
The South Holland team ranks No. 1 in the Chicago Sun-Timespre-season poll because it returns four starters from last year'sClass AA fourth-place finisher, including perhaps the state's bestbattery of junior pitcher Tina Zuccolo (21-2) and DePaul-boundcatcher Aimee Benson.
"In this game, good pitching stops good hitting," Thornwoodcoach Gary Lagesse said. "If she is on, Tina has the potential todominate almost any team. She'll be better than last year. Thisyear, I think the mental aspect will be different for Tina. She isgoing to step on the mound and own it."
Juniors Michelle Venturella, the all-state tourney firstbaseman, and Emily Prno, last year's DH, add punch to the lineup.Senior outfielders Kris Paarlberg and Tracy Beard will be keyshitting behind Venturella.
A difficult schedule includes Merrillville, Ind., Rich South,Stagg, Andrew, Lockport, Providence, Joliet-St. Francis andDownstate powers Washington, Bartonville Limestone and Casey.
"We have a lot of holes to fill but a good pitcher can hide alot," Lagesse said. "Our young kids have to come through for us to besuccessful."
Four All-Chicago Area performers return - Carl Sandburg firstbaseman Jenny McGuinness, Providence second baseman Amy Ernst, St.Francis de Sales shortstop Julie Frain and Mundelein outfielder Ashley Struggles.
Here's a look at the area's Super 25:
1. Thornwood: The T-Birds will start sophomores MichelleZeiger and Shannon Hudson on the left side of the infield. Lagessefeels Zeiger "is a gift wrapped athlete" who will be his rookie ofthe year. She has been clocked in 5.2 seconds for the 40.
2. Joliet-St. Francis: Coach Terry Benter returns sevenstarters from last year's sectional finalist. Pitcher Julie Thontlinleads the cast, which includes catcher Maria Miskuska, first basemanJenny Piazza, Joyce Subar, Cam Worland, Jana Meader and Shelly Birsa. It is the school's final season before its fall merger with JolietCatholic. The tough schedule includes a trip to Moline next week and a late April doubleheader with Thornwood.
3. Carl Sandburg: McGuinness (.404. eight HR, 44 RBI) carriesthe big stick, sophomore ace Jenny Crabb returns to the mound andshortstop Missy Kies and outfielder Sherry Muszanski lead the defensefor last year's SICA North champion (29-5). The Eagles are mendingfrom assorted injuries, including two broken noses and infielder MaryTorgeson's arthroscopic knee surgery.
4. Andrew: The Thunderbolts are young but experienced.Shortstop Lesa Arvia and catcher April Prete will key the offense andsophomore Stacy Zarembski is the top pitcher. Two freshmen to watchare infielders Shannon Sands and Carrie Pryblski.
5. Lockport: The Porters return two Division I signees, DedeOdle (Eastern Illinois) and Kara Manley (Indiana). Also back areshortstop Dawn Troutman and outfielder Lisa Ebenrith. Sophomorepitcher Amber Podlesny (22-6, 0.90 ERA), who replaced graduatedsister Leigh on the mound, returns to battle Andrew for the SICA Westtitle.
6. Stagg: Last year, coach Darrell Walery's team was 27-7 andgot respect. With returning pitchers Heidi Neal, Cindy Woods andMichele Meier - who all play in the field when they aren't on themound - leading an experienced squad, the Chargers will challenge Sandburg in the SICA North.Other returning starters are Dana Oleskiewicz and Felcia Larson.
7. Lyons: The West Suburban Silver favorite returns pitcherKristie Hoheisel (10-4, 1.30 ERA) and its entire infield of KarenKajmoicz (19 RBI), Jenny Galto (.445), Maria Siambekos (.383) andslick-fielding shortstop Laura Perek. An improved schedule will testthe Lions, who should have plenty of savvy with key members of theClass AA volleyball state champion.
8. Prospect: The Knights are favored for an eighthMid-Suburban South title. Senior pitcher Jennifer Hernet returnsafter leading Prospect to a 23-6 mark. Also returning are catcherBecky Thorne and outfielders Lori Moore, Laura Lynch and MarisaUrkovich. Sophomore shortstop Aimee Smith, last year's top newcomer,solidifies the infield.
9. Aurora Central: The Chargers are the best in Class A andfavored over Nazareth in the Private League. Three pitchers return -Kelly LeFevre, Kristy Lang and Katie Feltes. Lynn Piscoran, CarrieFranck and Lori Berenyi are solid in the infield and Kallin Vance isthe best outfielder.
10. Washington: Pitcher Johnna Flavell, a transfer from Harlan,figures to give Washington an edge over Taft in the Public League.The New Zealand native is one of the fastest pitchers the city hashad. Third baseman Julie Kawiecki and outfielder Tami Hoff (.410)are offensive catalysts. Judy Simmons, a transfer from Hammond(Ind.) Bishop Noll, and Colette Bosko provide power.
11. T.F. South: Pitchers Shay Wilson and Amy Brewe return forlast year's 21-5 SICA Central powerhouse. The infield is solid withKara Koselke, Debbie Jaroscak and Ellen Kolberg. The key will becoach Dominic DiLeo's ability to build an outfield.
12. Harvard: Cori Lagerhausen (21-2, 0.62 ERA) hurled theHornets to last year's Elite Eight before running into Casey.Harvard was 26-3 last year and could be even better with returningstarters Kari Ritenour, Karla Kruse, Kathy York, Amy Pack and AnnStalo.
13. Hersey: The defending Mid-Suburban champion, withfirst-year coach Al Beard, returns pitcher Debbie Gerdes, NatalieQuinn, Jenny Schultz and Stephanie Jursa. The Huskies have handledProspect in the last two MSL title games and hope this is the yearthey can get by the Knights in the regional.
14. West Chicago: Pitcher Kelly Mathews and the Wildcats were22-5 last year and tied Class AA runner-up Naperville Central for theDu Page Valley title. This year, they are aiming for Pekin.Shortstop Angie Webb is a career .400 hitter. The outfield is onethe best in the area with Theresa Wilson, Missy Vega and MelodyBenson. Laurie Davidson and Sue Thomas are the top infielders.
15. Morris: The Redskins rate an edge over Plainfield in theLittle Seven with pitching ace Kindra Phelps (20-5), who hit .395,back after knee surgery in August. First baseman Jen Wethington(.480) and cleanup hitter Janee Matteson (.344) add plenty of punchand are solid defensively.
16. Mundelein: Susan Musselwhite, 1988 Player of the Year,graduated. But Struggles, pitcher Lynette Kowalke and Cindy Sharkgive coach Jim deRivera a strong enough nucleus for a slight edgeover Zion-Benton and Warren in the North Suburban. Also back fromlast year's Elite Eight qualifier are Michelle Strachn, DemiMichelou, Deanna Deal, Kim Burns and Katie Magoon.
17. IHM: If she can avoid injuries that shortened her last twoseasons, junior Katie Clifford (12-5, 0.91 ERA, 1.8 strikes perinning) could be the dominant pitcher in the western suburbs. Tigerscoach Dave Power plans to use his ace less early in the season soshe's in top form at tournament time. Runs will come in bunches withKristen Dybas, Debbie Kalinski and Stacey Petruncio igniting theoffense.
18. Rich East: Six starters return for the defending SICA Southchampion. The best is first baseman Kerri Tanksley (.500). Alsoback is catcher Jenny Murphy, who hit .431 before breaking her leglast season, Carrie Buckner, Angie Shoyer and Sarah Arndt. The keywill be Angie Alessandrini, who was 8-2 as the Rockets' No. 2 hurlerlast year.
19. Rolling Meadows: The Mustangs return 11 letter-winners andcoach Greg Benes figures to have his best team since winning the 1984MSL title. The keys are Stacey Boron (.400), Jill Gregory, KimAnderson and Debbie Dreyer, a speedy pitcher-outfielder who has neverbeen caught stealing.
20. Maine South: Coach Don Kerr has a rebuilding job afterthree straight trips Downstate. He's done it before and boasts a234-51 career record. Shortstop Jenny Warno, catcher Jenny Smith,Diane Wold and Emily Pasier are the top returnees. Kim Wiederer andJane Steffen figure to share pitching duties. The Hawks figure to bein a tight racewith Evanston, Maine East and New Trier in the Central Suburban Southand Kerr gives them an edge.
21. Zion-Benton: Jennifer Linna (16-3) and leading hitter JillMartin (.467) return from last year's 24-4 team with Heidi Rhodes andJessica Conti. The key will be how fast the Zee-Bees' 13 juniorsdevelop.
22. Oak Park: The Huskies return three-time all-conferenceselection Elly Vitacco and super sophomore Danielle Tyler from lastyear's 27-7 squad to solidify the infield. Last year's backuppitcher Julie Ieronemo may be the key if the Huskies are to challengeLyons in the West Suburban Silver.
23. Bloom: Coach Mark Anderson's Trojans lost to Rich East inthe regional final in nine innings. They'll be better. But willthey be good enough to challenge Thornwood in the SICA East?DePaul-bound shortstop Jenny Bruno, Lisa Wells, pitcher Dawn Johnson,Cathy Price and Monica Perkins are the keys.
24. Maria: The defending GCAC champion returns first basemanJenny Madden, outfielder Andrea DiGrazia and catcher Dawn Jacksonfrom last year's regional champ. Pitching is a question mark.
25. St. Francis de Sales: Junior pitcher Jennifer Iwaszkoshowed flashes of brilliance last year and should help the Pioneerschallenge in the GCAC. Also returning are Frain, Colleen Sabin andKerrie Dawson.
The year will soon come to an end, and that means it will not be long until the General Assembly starts its new session in January.
Trying to figure out what will be on the plate for legislators during the next session is anybody's guess.
But here are what a chamber president, lobbyists and lawmakers hope are tackled and not tackled on Capitol Hill next year.
"Lowering business taxes - they (the Legislature) haven't addressed it enough," said Harriet Faren, president of Lebanon Valley Chamber of Commerce. "We feel they (business taxes) are unfair, excessive and do not make Pennsylvania competitive."
In comparison with other states, Pennsylvania does not provide enough incentive for businesses to open here, Faren said. And healthcare costs are another issue Eaten said the General Assembly needs to address.
Many employers carry health insurance for their employees, but it is becoming increasingly difficult for employers to cover most of the cost, Eaten said. Employees are being asked to pitch in more from their paychecks for health insurance.
"It costs the employee more, or they become underinsured or not insured at all," Faren said.
Environmental reform is another issue LVCC hopes is brought to the table next session. The state's environmental regulations for companies are set above federal standards and are bad for business, Faren said.
David Taylor, executive director of the Pennsylvania Manufacturers' Association in Harrisburg, made the same point about the state's environmental regulations.
Taylor also wants to see the Legislature reform worker's compensation laws and control government spending. He said politicians in Harrisburg should not be allowed to spend taxpayer money faster than it is earned by taxpayers.
The state should also adopt The Fair Share Act, which would even the playing field for companies that are asked to pay the entire amount of employees' health-care costs even though they are not entirely responsible for their injuries, Tay lot said.
"Right now, there is the deeppockets rule. Even if you are not entirely responsible for a worker's injury, if the other party cannot pay, you are responsible," Taylor said.
If adopted, the Fair Share Act would not hold an employer responsible for an employee's entire medical bill should other parties share the blame for an injury. If multiple parties are responsible for an accident, even if all cannot pay, the employer is not made to pay all costs.
Money is on many observers' minds when the topic of the General Assembly and issues it should address is raised.
The Greater Harrisburg Association of Realtors does not want to see the state earn extra money on additional taxes placed on homeowners, said Kathy Ludwig, executive vice president for the GHAR.
GHAR is against impact fees and increases to realty transfer tax and property taxes, Faren said.
"We want people to be able to afford homes," Ludwig said. "An overall objective of ours is to not have anything impede housing affordability."
Taxes are always an issue for the General Assembly, and next session will be no exception. Senate Majority Whip Jeffrey Piccola (R-Dauphin and York counties) will push for the lowering of several taxes.
Piccola wants to cut the corporate net income tax rate, establish a single sales factor for CNI, work to keep the personal income tax low and ensure the governor follows the law for the phase out of the capital stock and franchise tax.
The senator would like to see employment and health-care costs lowered to meet the rates of other states and will support the re-enactment of the Fair Share Act of 2002.
Overall, Piccola wants to see less governmental interference when it comes to regulations imposed on the business community.
"Reduce hidden and unnecessary costs caused by government red tape," Piccola said.
Pennsylvania state employee and school district employee pensions are on the mind of state Rep. Steven Nickol (RAdams and York counties). And he thinks they should be a priority for the General Assembly next session or soon after.
"We have to look at it because as it stands now, we are defying reality," Nickol said. "In both cases, we (the state) are contributing a floor rate of 4 percent, and next year it will go down to zero.
Nickol introduced House Bill 2562, which would require the state to continue to contribute each year to both pensions or by 2013 each will see double-digit leaps, he said.
"The employer rate needs to gradually increase, or it will spike much higher in 2013," Nichol said. "We keep putting it off."
Public transportation funding and school funding are two other issues Nickol said he hopes the General Assembly addresses next year.
As it stands now, 62 percent of state subsidies provided to school districts are based on growth figures dating back to 1991, Nickol said. And although 150 school districts are growing, 350 are dropping in population, and many districts growing at a rapid rate are underfunded, Nickol said.
"It has to be dealt with. It gets worse every year," Nickol said. "And after 16 years, there is disparity."
WINFIELD - Putnam County Family Court Judge William Watkins spendshis days with a constant flow of people plagued by tense domesticconflicts.
But by evening, the former Marine spends his time with some lovelyladies named Countess Celeste, Rio Samba and Miss All-AmericanBeauty.
If it sounds a bit risque, relax.
The judge, who goes by the nickname Chip, counts those stunningspecimens among his bevy of about 100 rose bushes. It's a hobby he'shad since he was a boy.
"They don't talk back," said Watkins, 54, of the contrast the rosegarden provides to his position as the county's only family courtjudge.
Watkins oversees more than 2,000 hearings a year, including allPutnam County divorces, custody disputes and domestic abusecomplaints. It can be stressful, he says, dealing with people who areupset and contentious.
The roses pose their own challenges.
They can easily become victims of too much water, too littlewater, extreme temperatures, disease and insects.
"Not all rose bushes are going to do well. They don't all makeit," Watkins said. "When they die, I plant another one."
Watkins favors old-fashioned, or antique, roses for their beautyand scent. He also is willing to try out experimental new roses fromlocal garden centers.
The multi-level rose garden bordering his Winfield home wasconstructed with raised beds and a stepped walkway. The entire gardenhad to be wrapped in netting to deter deer.
"My grandfather was a judge in Taylor County," said Watkins. "Andthat's where I started learning about roses. I remember my AuntNettie; she'd con us into making it fun.
"She'd have us dropping Japanese beetles into a can, and thenshe'd smash them with a brick," said Watkins. "That got me started atan early age."
As a junior high and high school student, he planted roses at hishome in South Charleston. And when he returned to West Virginia fromMarine Corps stints in Okinawa and Los Angeles, he took up rosegrowing again.
"I started out small and I kept getting more and more," Watkinsexplained.
While entering rose shows isn't his favorite activity, he has wonawards at local competitions.
"I'm very competitive but not when it comes to roses," he said. "Ijust enjoy playing in the garden."
Watkins keeps a detailed notebook about his roses, their origin,their care, their placement in the garden and their performance. Buthe doesn't usually need to refer to it to know their names.
Double Delight, Fourth of July, Mister Lincoln, David Austin, RiaSamba and the rest - he can rattle off the names and the attributesof each. While some are newer bushes, others have been with him aslong as 20 years.
His arms bear the marks of a rose grower - many scratches. Hekeeps his pruners in his pocket so he's always ready to snip somedead flowers or bring in armfuls for his wife, Rhonda, to enjoy.
"I love it," she said, pointing out her favorite roses in thegarden.
"I'm pretty good at arranging them."
Watkins, a graduate of West Virginia University School of Law, waselected as Putnam County's first family court judge in 2002.
Contact writer Cheryl Caswell at cherylc@dailymail.com or 348-4832.
LARAMIE, Wyo. (AP) — Air Force thrives in fourth quarters and on fourth down.
Tim Jefferson ran 7 yards for the decisive score late in the fourth quarter and Jared Tew ran for 136 yards and a score to lead Air Force past Wyoming 20-14 on Saturday.
Wyoming (1-3, 0-1 Mountain West Conference) blocked the extra point after Jefferson put the Falcons up 20-14 with 3:41 remaining, but Air Force forced a turnover on the Cowboys' next possession when Jon Davis recovered a fumble by Wyoming's David Leonard.
Air Force (3-1, 2-0) then ran out the last 2:50.
Last weekend, a 14-0 run by Air Force in the fourth quarter made Oklahoma sweat in Norman. This time two fourth quarter touchdowns was enough to come away with a victory.
Coach Troy Calhoun praised his players' resilience.
"You've got to continuously be able to be the lions and tigers and be able to scent some food out there," Calhoun said.
Air Force made fourth downs count, too, converting 4 of 5 times to keep critical drives moving against Wyoming (1-3, 0-1).
"Whatever it takes, we have a mental mindset that we're going to make things happen. We had some big first downs," Tew said.
Jefferson finished with 94 yards rushing. The Falcons finished with 374 yards rushing, a bit less than their best-in-the-nation rushing average.
Alvester Alexander ran for 123 yards and two touchdowns for Wyoming, which had 174 yards rushing and ran the ball better than its last two games, blowout losses to Texas and Boise State.
"Our schemes were good on both sides of the ball. Our players worked hard from start to finish," Cowboys coach Dave Christensen said. "We just have to be a bit more physical."
Austyn Carta-Samuels threw 6 of 11 for 66 yards and had 60 yards rushing for Wyoming. Jefferson also threw for 66 yards and was 5 of 12.
Air Force dialed things up after Wyoming got ahead in the third quarter. Alexander snaked in from 9 yards out to put the Cowboys up 14-7.
"We definitely felt the urgency to put points back on the board at around that point in the game," Jefferson said.
Air Force tied the game 14-14 on a 9-yard run by Nathan Walker a few minutes into the fourth. A 42-yard punt return by Ghaali Muhammad was about all that Wyoming could muster on its next brief possession.
An 80-yard Air Force drive followed, including a 5-yard run by Tew on fourth down and, ultimately, the Falcons' winning touchdown.
The game was tied 7-7 at halftime.
Wyoming was first to score when Alexander ran in a 1-yard TD. Air Force scored on a 4-yard run by Tew with 2:24 left in the half.
UPS Inc., the world's largest shipping carrier, is scheduled to report second-quarter results on Thursday. The following is a summary of key developments and analyst opinion related to the period.
OVERVIEW: The Atlanta-based company, also know as United Parcel Service, along with rival FedEx Corp. are seen by economists and analysts as bellwethers of the global economy, since they deal with such basic indicators of company health as orders and product shipments.
UPS has seen weaker package volume due to cutbacks by businesses amid the U.S. recession.
The company has been cutting costs and jobs. An executive has said UPS cut 10,000 domestic jobs in the first quarter through attrition and part-time employees leaving and not being replaced.
The company previously said economic indicators suggest recovery in the U.S. might begin late this year, but more likely not until 2010.
BY THE NUMBERS: Analysts surveyed by Thomson Reuters, on average, expect UPS to post second-quarter earnings of 49 cents a share on revenue of $11.02 billion. Analysts generally exclude one-time items from their estimates. UPS has said previously it expected to post second-quarter earnings per share in a range of 45 cents to 55 cents. It also said it expected U.S. domestic package volumes to decline 4 percent to 6 percent in the April-June quarter. A year ago for the second quarter, UPS posted a net profit of 85 cents per share on revenue of $13 billion.
ANALYST TAKE: Standard & Poor's analyst Jim Corridore, in a recent research note, reiterated his "Hold" opinion on shares of UPS. He said UPS' second-quarter results would likely be affected by weak volumes and pricing. "We are not expecting UPS to say they are seeing strengthening demand, but will be looking for signs that demand has bottomed," he said. Despite the down economy, Corridore said that UPS is likely to remain a strong cash generator.
WHAT'S AHEAD: UPS has said it won't furlough any of its pilots through April 1, 2010, after the union reached a deal with the company announced in June that includes more than two-thirds of the cost cuts the company wanted. UPS has said the Independent Pilots Association identified savings totaling roughly $90 million over three years through pilots taking short- and long-term leaves of absence, military leaves, job sharing, reductions in flight pay guarantees, early retirement, and sick bank contributions. UPS sought $131 million in pilot savings over the next three years to avoid furloughing, or idling, roughly 300 pilots. The IPA said it would continue to work this year to produce additional savings.
STOCK PERFORMANCE: UPS shares rose less than 1 percent during the second quarter, on a split-adjusted basis. Accounting for a dividend issued during the quarter, UPS shares closed at an adjusted price of $49.64 on April 1 and ended the quarter June 30 at an adjusted price of $49.99.
___
On the Net:
UPS Inc.: http://www.ups.com
Officials of The Philadelphia Inquirer National Sudoku Championship are investigating suspicions of cheating.
The focus is on Eugene Varshavsky, who placed third out of 646 competitors and took home a $3,000 prize on Saturday.
Officials say Varshavsky blazed through the second round but couldn't finish the easy first steps in the championship puzzle. They say that raised a red flag.
Tournament spokesman Jay Devine said officials expect to complete their investigation in a few days.
Varshavsky could not be reached for comment. There is no telephone listing for anyone named Varshavsky in his hometown of Lawrenceville, New Jersey.
Tammy McLeod of Los Angeles won first place in the tournament, earning her $10,000 and a spot on the World Sudoku Team that will compete next spring in Philadelphia.
The chief executive of a leading Taiwanese LCD screen maker has been barred from leaving the U.S. during a U.S. Justice Department probe into alleged price-fixing, the company said.
Hsinchu-based AU Optronics Corp. said in a statement filed Saturday with Taiwan's Stock Exchange that a U.S. court has demanded its chief executive, Chen Lai-juh, stay in the United States until his trial on price-fixing allegations begins. Chen traveled to the U.S. earlier to prepare for his defense, the company said.
A federal grand jury in San Francisco indicted AU Optronics's Houston-based U.S. subsidiary and six company officials, including Chen, in June on charges of conspiring to fix prices of LCD panels worldwide from September 2001 to December 2006.
LCDs, or liquid crystal displays, are the flat display screens used in many laptop computers, cell phones and new TVs.
The U.S. Justice Department has accused a number of Asian LCD manufacturers of selling the screens at illegally fixed prices to companies including Apple Inc., Dell Inc. and IBM Corp.
According to the Justice Department, six LCD suppliers have pleaded guilty to price-fixing charges and have been ordered to pay fines totaling more than $860 million.
Among Taiwanese LCD makers, Chunghwa Picture Tubes Ltd., Chi Mei Optoelectronics Corp. and HannStar Display Corp. have all pleaded guilty and paid fines of hundreds of millions of dollars.
Analytical method validation (AMV) is required in the biopharmaceutical industry for all methods used to test final containers (release and stability testing), raw materials, in-process materials, and excipients.1 AMV is also required for test methods that are used to validate the process prior to process validation. This article reviews current regulatory guidelines and the critical elements of analytical method development (AMD) that should be finalized before starting AMV.
Regulatory Guidelines
Analytical methods are non-microbiological procedures which are used to test final containers, raw materials, in-process materials, and excipients for release or to determine stability. Guidance for microbiological test method validation is reviewed in the Parenteral Drug Association (PDA) Technical Report No. 33 and is outside of the scope of this guide.2 The International Conference on Harmonisation (ICH)'s Q2A and Q2B and the United States Pharmacopoeia's USP 28 <1225> provide basic guidance.3-5 However, following just these guidelines may not provide sufficient evidence that a method is suitable for product release.6,7 FDA provides guidance on some of the issues that are not currently covered elsewhere.8,9
In addition to compliance, a biopharmaceutical manufacturer must consider how the acceptance criteria for the process validation and all corresponding test methods are connected to the statistically derived product specifications that support acceptable product release-to-reject ratios.6,7 This article addresses three major deficiencies in the available guidelines:
* the lack of clear expectations concerning when to qualify, validate, and verify test methods
* the lack of clear expectations concerning when certain method performance aspects should be covered (AMD or AMV)
* the lack of guidance for setting AMV acceptance criteria that directly impact product specifications and predicted product release-to-reject ratios, which could ultimately impact patients and firms.
Qualify, Validate, or Verify?
The US Code of Federal Regulation 21 CFR 211.194(a)(2)) does not require recognized standard reference methods that have already been validated and published in a standard reference (such as USP 28) to be fully revalidated.1,5 However, a biopharmaceutical firm must verify the suitability of these validated and published methods for their specific product and laboratory environment.5 The verification of the suitability of methods under actual conditions of use is acceptable in the following cases:
* the methods are published in the current revision of the USP
* the methods are published in the Association of Official Analytical Chemists (AOAC) Book of Methods or another recognized standard reference
* the methods are detailed in an approved new drug application and the referenced method is not modified.1
In addition to the validation of new methods and the verification of previously validated methods, there is a third category, analytical method qualification (AMQ), which can be used under appropriate circumstances. However, before AMQ can be used, the exact scope or applicability and the detailed definitions for all three AMV categories must appear in a firm's written procedures. Table 1 summarizes the general expectations for the applicability and requirements for using one of these three validation strategies.10-12
Which Performance Criteria?
The final AMV document must include evidence that a particular test procedure is suitable for its intended use. Formal method validation studies should include all relevant ICH Q2A/B AMV characteristics listed in Table 2. The AMV protocol includes all scientifically justified and logical step-by-step validation studies. Whenever a test method is developed and will be used for drug development from Phase IIb onward, material for lot release, raw materials, in-process, or excipients, the AMD studies should contain a series of critical elements. The evaluation of AMD characteristics should precede AMV and should be summarized in an AMD report.6,7 All AMD data should ideally be generated in a GLP/GMP environment using qualified equipment operated by qualified personnel, properly documented, summarized in an AMD report, and approved by quality assurance (QA). These results can be used as a qualified method for material tested before Phase IIb.10 This also ensures that all AMD/AMQ data and results (summarized later in the AMV protocol) are valid from a compliance perspective. Critical method performance criteria that should be evaluated during AMD are described below. The main argument for evaluating these criteria during the AMD phase is to ensure that a test system is truly optimized before AMV. The validation process should not be a trial-and-error effort but rather a formal process demonstrating that all AMV acceptance criteria are readily met.
AMV Characteristics
Assay performance criteria such as accuracy and specificity are defined for analytical methods in current guidelines and should always be covered during AMV according to assay classification.3,4 The validation characteristics for each test method category are listed in Table 2 and briefly described below. The five ICH Q2A/B test categories are listed across the top row of Table 2, and the corresponding product specifications which would trigger the selection of one of these five categories are listed in the second row. For example, a test that reports levels of a characterized impurity should be validated as a quantitative limit test, and the AMV should include a formal evaluation of a total of seven characteristics.12,13 On the other hand, a qualitative limit test for an impurity will have product specifications reported as less than a particular pre-set limit. The actual impurity concentrations are not reported; only the detection limit (DL) and specificity are required AMV characteristics. We are not quantitatively reporting this result, so we are not required to evaluate the quantitative method characteristics.
Accuracy is usually demonstrated by spiking an accepted reference standard into the product matrix. Percent recovery (observed/expected x 100%) should ideally be demonstrated over the entire assay range using multiple data points for each selected analyte concentration. Demonstrating accuracy is mostly affected by how well the reference standard is characterized and how well systematic sample preparation errors are controlled. Data generated for determining accuracy may be used for other validation characteristics, such as repeatability precision, linearity, assay range, and quantitation limit.
Repeatability precision indicates how precise the test results are under ideal conditions (same sample, operator, instrument, and day). Repeatability precision should be demonstrated over the entire assay range, as with accuracy. Accuracy data may be used.
Intermediate precision indicates how precise test results are on any given day. Intermediate precision should be demonstrated by generating a sufficiently large data set that includes replicate measurements of 100% product (analyte) concentration. Data should be generated in a well-designed matrix by several operators over several days using different instruments. If other critical assay elements (such as different columns in HPLC) are expected to significantly contribute to assay variability, they also should be integrated into the execution matrix. Different analyte concentrations over the entire assay range can be used to demonstrate intermediate precision, but the results must be converted to percent recoveries before they can be statistically compared.
Assay specificity is usually ensured by demonstrating insignificant levels of matrix interference and analyte interference. The matrix may interfere with assay results by increasing the background signal (noise), or matrix components may bind to the analyte of interest, potentially changing the assay signal. Spiking the analyte into the liquid product and comparing the net assay response increase versus the expected assay response provides information on potential interference. Other analytes that may be present in the product matrix should be spiked in proportional concentrations into the matrix (keeping final analyte concentrations constant). Results of unspiked versus spiked product should be compared.
Linearity of the assay response demonstrates proportionality of assay results to analyte concentration. Accuracy data may be used to evaluate this parameter. Linearity should be evaluated through a linear regression analysis - plotting individual results of either analyte concentration versus assay results or observed versus expected results. However, many biological assays are not linear, even after data transformation (such as logarithmic conversion). The overall fit of the curve for biological assays within the proposed assay range should not be evaluated by this validation characteristic.
A method's assay range must bracket the product specifications. By definition, the quantitation limit (QL) constitutes the lowest point of the assay range and is the lowest analyte concentration that can be quantitated with accuracy and precision. In addition to establishing the accuracy and precision of all analyte concentrations within the assay range, the assay response must also be linear (if applicable) as indicated by the regression line coefficient.
An analyte's detection limit (DL) is the concentration that yields a response significantly different from a blank or background signal. ICH Q2B suggests three different approaches for determining the DL. Other approaches may be acceptable if justified.
The QL is the lowest analyte concentration that can be quantitated with accuracy and precision. Since the QL constitutes the beginning of the assay range, the assay range criteria for linearity (if applicable) must be passed for the particular analyte concentration determined to be the QL.
It is important to remember that AMV provides the formal evidence that a test method is suitable for use under strictly controlled QC-testing conditions. The AMV protocol should be setup to deliver this evidence through appropriate acceptance criteria by varying sample batches, concentrations, operators, instruments, days, and other factors that are expected to vary during routine testing - within established sample and system suitability conditions and operational limits.6,7
AMD Characteristics
All analytical procedures are associated with bias. It is particularly true for biological assays that test for the purity, potency, and molecular interactions of biopharmaceuticals. If the product is unique, appropriate reference standards may not be available. The evaluation of the assay's accuracy and bias can be the most difficult part of the development and validation process. When replacing a method, comparing the results of the new method to those of the old method is often meaningful only when assay bias is taken into consideration. If we can compensate for the bias by modifying release specifications, we should be able to properly assess the quality of the process and the product and remain in compliance. Whenever relative percentages of various analytes are estimated using a single assay, the response factors must be established and integrated (normalized) into the calculations in order to consistently report accurate purity and impurity levels.6,7
Samples, standards (secondary, inhouse, or working), controls, and critical reagents should be evaluated for degradation during storage and potential freeze-thaw cycles. The negative effects of time on the bench during actual testing (room temperature), repetitive freeze-thaw cycles, and long-term storage of all materials used to generate test results should be evaluated and expiration times should be established.
The test system must be properly controlled to ensure reliable release-testing results. System suitability criteria should be established at the end of AMD, usually by running a set of control points. For each test, results are considered valid if all control points are within established limits. A test system must be able to reproduce measurable results of a homogeneous sample (control) to allow examination of differences among various product batches.
Sample suitability should be established during AMD and should ideally ensure that samples, controls, and standards are prepared identically and run simultaneously. In addition, sample suitability should include a statistical analysis of the number of replicates needed to generate significant release results. Single measurements may be acceptable if the production-process sampling can deliver truly batch-representative samples and the precision of assay repeatability is high compared to the product specifications (and therefore high compared to the batch-tobatch variation upon which these specifications are based).
Sometimes, data transformation (for example, logarithmic conversion) may lead to improved linearity for essentially non-linear assay responses. However, many biological assay response curves are not linear even after transformation.12,13 These are particularly difficult and should only be handled by experienced statisticians. Just as different test methodologies have different biases, changing statistical models may significantly change the final results. Some models may be inappropriate or may not provide acceptable results over the entire assay range.
Robustness, the lack of a significant effect when small changes are deliberately introduced into the test system, should ideally be addressed during method optimization and not as part of AMV. We should know a method's degree of robustness before starting formal AMV. Critical test system parameters (for example, the acceptable range of diluting the test sample) must be identified and controlled with appropriate operational limits. These limits should be described in the AMD report and documented in the method SOP. The SOP contains operational limits within the context of the overall system suitability criteria. These limits must be adhered to during validation. In addition, robustness should be tested in the AMD phase during or after method optimization because significant differences in the AMV results may be difficult to explain.
AMV Protocol Acceptance
Why must we set protocol acceptance criteria? One answer is that we always must validate against limits or specifications, just as release testing results are compared to specifications. Only when all validation results are within established limits is an AMV considered acceptable (assuming that all limits were reasonably set). In addition, a validation document is a contract that not only defines in detail the test parameters but also the exact conditions and contingencies (acceptance criteria). All signing parties agree to the acceptance criteria before the protocol is executed. We must derive appropriate acceptance criteria so validations that should fail do fail and vice versa. Acceptance criteria should demonstrate to regulatory authorities (and ultimately patients) that quality systems and production processes are well designed and maintained to ensure consistent product quality. We also must satisfy acceptance criteria to remain in compliance.14
Deriving reasonable AMV protocol acceptance criteria is one of the most difficult AMV tasks. In general, the most critical AMV characteristic for the quantitation of excipients, product potency, and impurities in biopharmaceutical manufacturing is intermediate precision. It provides very valuable information concerning the overall contribution of assay variability to the observed process variability. Accuracy is often of lesser concern because we are mostly concerned with batch-to-batch consistency and how well release batches match the purity and impurity levels of the clinical reference batches.6,7
When setting AMV intermediate precision acceptance criteria, one may only know the observed production-process variability. The best approach is to derive acceptance criteria for intermediate precision from historical process data (observed or expected batch-to-batch variability and content uniformity) and the product specifications (existing or target). The AMV protocol should not permit test method variability to be so high that we could face not being able to release product batches with results that should have fallen within specifications, or vice versa, release product batches with results outside of specifications.14 Establishing an efficient AMV execution matrix has been discussed elsewhere.6,7
Conclusions
In addition to satisfying regulatory requirements, AMV enables reasonable product specifications to be set and helps separate actual process variability from test method and sampling variability. AMV does not improve a test method but merely provides evidence for its suitability and the confidence in reported results. The quality of the development work determines the quality of the test method and, therefore, the quality of the production process and the product.
[Reference]
References
1. FDA. 21 CFR 211, sections 165(e) and 194(a)(2). Available at: www.fda.gov.
2. PDA. Evaluation, validation and implementation of new microbiological testing methods: PDA Technical Report No. 33. PDA Journal of Pharmaceutical Science and Technology 2000; 54(Suppl. TR33).
3. ICH. Validation of Analytical Procedures. Q2A. Federal Register 1995; 60.
4. ICH. Validation of Analytical Procedures: methodology. Q2B. Federal Register 1996; 62.
5. United States Pharmacopoeia. USP 28 <1225>. Validation of Compendia/ Methods.
6. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part I: development and optimization. BioPharm International 2004; 17(10):52-61.
7. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part II: formal validation. BioPriarm Internationa/ 2004; 17(ll):46-52.
8. CDER. Guidance for Industry. Bioanalytical Method Validation. Bethesda MD: FDA; 2001.
9. CBER. Draft Guidance for Industry. Analytical Procedures and Methods Validation. Bethesda MD: FDA; 2000.
10. Ritter N., et al. What is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess International 2004; 2(8):32-47.
11. Krause SO. Good analytical method validation practice, part I: setting-up for compliance and efficiency. Journal of Validation Technology 2002; (9):23-32.
12. Krause SO. Good analytical method validation practice, part II: deriving acceptance criteria for the AMV protocol. Journal of Validation Technology 2003; (9):162-78.
13. Krause SO. Good analytical method validation practice, part III: data analysis and the AMV report. Journal of Validation Technology 2003; (10):21-36.
14. Krause SO. Analytical method validation. Presented at IVT's 10th Annual Meeting; 2004 Feb 25-28; Philadelphia, PA.
[Author Affiliation]
By Stephen O. Krause, Ph.D.
[Author Affiliation]
Stephan O. Krause. Ph.D., validation manager of QC assay support. Bayer HealthCare LLC, 800 Dwight Way. Berkeley, CA, 94701-1986. 510.705.4191. stephan.krause.b@bayer.com.
NEW YORK - 200 episodes is a long, long time. But somehow it'shardly surprising that "Law & Order" (10 p.m., NBC, TV-14) hasreached that milestone. Since debuting in September 1990, this Emmyaward-winning drama has had a revolving door of quality talent,including the departed Christopher Noth, Paul Sorvino and MichaelMoriarty.
We can now add Detective Curtis (Benjamin Bratt) to that list. Ina press release, series creator and executive producer Dick Wolfpraised Bratt as "a consummate professional and a terrific actor."He said that "my hope is that he will return as Curtis as ourfranchise expands." Wolf has plans to spin off a new series about asex crime unit, "Law & Order: SCU."
Curtis will leave the NYPD on the program's season finale on May26 after deciding to spend more time with his wife as she battlesmultiple sclerosis. Bratt will be replaced by Jesse L. Martin, whoviewers may recognize from his recurring roles as Ally's loveinterest on "Ally McBeal." Martin is nothing but enthusiastic aboutthis development. "I am extremely excited about joining the show. Iam grateful to work on such a superb show with such a stellar castinthe greatest city in the world."On tonight's episode: McCoy thinks it's murder when a famous richman dies mysteriously after taking an overdose of a performance-enhancing sex drug. Julia Roberts ("Pretty Woman") guest stars as awitness (and possible suspect) attracted to Det. Curtis. Bratt andRoberts have been romantically linked in real life.In other programming, dozens of past and present country starsappear and perform on the 34th Annual Academy of Country MusicAwards(8 p.m., CBS). Garth Brooks, Faith Hill, Jo Dee Messina, GeorgeStrait and Dixie Chicks have all been nominated for the Album of theYear. Brooks and Strait are also in the running for the Entertainerof the Year award.And just in time for Mother's Day it's Mummy's night on Discovery.Brendan Fraser hosts and narrates the three-hour series dedicated todesiccated remains. "Animal Mummies: Creatures of the Gods" (8 p.m.)looks at how ancient Egyptians deified their pets and preserved themfor posterity; "Mummies: The Real Story" (9 p.m.) looks at mummiesthroughout the world and throughout history; and "Egypt Uncovered:Mummies - Into the Afterlife" (10 p.m.) explores how modernscientists use mummies to study ancient diseases. Fraser is the starof the upcoming thriller "The Mummy."CULT CHOICEA washed-up screen siren (Bette Davis) desperately seeks acomeback in the 1952 drama "The Star" (2:30 a.m., Turner ClassicMovies, TV-G).
The head of the U.S. team negotiating a new arms pact with Russia said Thursday that a three-day round of talks in Geneva was "productive."
Assistant Secretary of State Rose Gottemoeller told the 65-nation Conference on Disarmament that the two sides hope to give a progress report by July to their countries' presidents on replacing the 1991 Strategic Arms Reduction Treaty.
"We have been here in Geneva for the past three days with the United States delegation, engaged in productive talks with our Russian counterparts, working toward a START follow-on agreement," said Gottemoeller. The treaty expires Dec. 5.
She said presidents Barack Obama and Dmitry Medvedev had instructed their negotiating teams to seek an agreement further lowering nuclear arsenals, with effective verification measures based on what has been learned from implementing START.
There was no immediate comment from her counterpart, Anatoly Antonov, who is chief of the Russian Foreign Ministry's security and arms control department.
Medvedev's spokeswoman Nataliya Timakova said earlier this week that the talks may achieve progress on a new accord by the time Obama visits Moscow July 6-8.
British Foreign Secretary David Miliband welcomed the talks as bringing gains for both the U.S. and Russia, enabling them to cooperate on "meeting the real, shared threats they face."
Gottemoeller praised the conference for agreeing last week to negotiate a new treaty to ban production of highly enriched uranium and plutonium needed to create atomic weapons.
She urged the delegations to press on with negotiations and explore other areas so they can move toward Obama's vision of a world free of nuclear weapons.
START, signed by Soviet President Mikhail Gorbachev and President George H.W. Bush, led each country to cut its nuclear warheads by at least one-quarter, to about 6,000.
In 2002, then-presidents Vladimir Putin and George W. Bush signed the so-called Treaty of Moscow, which called for further cuts to between 1,700 and 2,200 operationally deployed warheads by 2012.
Failure to negotiate a replacement to START would leave Russia and the U.S. unable to inspect and verify each other's stockpile of nuclear warheads.
A Palestinian peace activist was named the winner of the 2010 Anna Lindh prize Tuesday for her work to promote nonviolence in the conflict between Israelis and Palestinians.
Jean Zaru, 70, has been a teacher of religion and ethics at a school in Ramallah and written several books about nonviolence. She will receive the 150,000 kronor ($19,000) award at a ceremony in Stockholm on June 10.
The Anna Lindh memorial fund said Zaru was awarded for her "tireless work to build up a true peace culture and bring attention to all people's right to honorable and fair lives."
The Anna Lindh award was established to honor the Swedish foreign minister who was stabbed to death in 2003. It supports those fighting prejudice and oppression.
Zaru said the prize has encouraged her to continue working against "violent and oppressing structures.
"Anna Lindh lived a life of commitment, to her home country, to human rights, to international law and to the United Nations. Now it is time to follow her commitment, not just with words but also with action," Zaru said in a statement.
Foreign journalists, from left, Korean Yong Tae-young, 41, a correspondent for public broadcaster KBS, SIPA agency photographer Alfred Yacobzadeh and French national Caroline Laurent, a correspondent for Elle magazine, are held by Palestinian gunmen from the Popular Front for the Liberation of Palestine in Khan Yunis refugee camp, southern Gaza Strip, Tuseday, March 14, 2006. Nine foreign nationals were kidnapped in protest against an Israeli raid of a West Bank prison. (AP Photo)
Palestinian police whisked foreigners to safety, and several international relief agencies closed in the Palestinian territories on Tuesday in response to the kidnapping of aid workers and journalists by angry militants.
Gunmen abducted 10 journalists and aid workers and vandalized offices linked to the U.S. and Britain, in the most violent campaign against foreigners in recent memory in the Palestinian territories. The mayhem was prompted by Israel's raid on a West Bank prison and seizure of a Palestinian militant leader and his accomplices in the assassination of an Israeli Cabinet minister.
Frightened foreigners sought refuge at Palestinian security headquarters, and a U.N. jeep came under fire as it tried to leave the coastal strip. Angry Palestinians accused Britain and the U.S. of complicity in Israel's siege of the prison.
By the end of the day, all but three of the kidnapped foreigners were freed.
The fury hit aid groups and organizations that have been working to alleviate the grinding poverty Palestinians face in Gaza, and it threatened to disrupt relief efforts.
"The European Commission deplores the attacks on member states' offices. The first to suffer are the Palestinian people," said Johannes Laitenberger, spokesman for the European Union's executive office.
The outbreak of anti-foreigner violence was the second in recent weeks. Reacting to Danish cartoons disparaging the Prophet Muhammad, angry Palestinians stormed European buildings and briefly held some aid workers. The relief teams had just started returning to the coastal strip when Tuesday's violence sent them scurrying for safety again.
Several international aid agencies, including the United Nations Relief and Works Agency said they were temporarily pulling their staff out of the West Bank and Gaza.
Officials said U.N. operations would not be affected, as the 8,500 local Palestinian workers would remain on the job, while 13 foreign U.N. staffers were leaving the Palestinian areas.
The kidnappings started shortly after Israeli forces surrounded the Jericho prison, demanding the surrender of Ahmed Saadat, the leader of a radical PLO faction, and four of his alleged accomplices in the 2001 killing of an Israeli Cabinet minister. A sixth militant was being sought on other charges.
In Gaza, gunmen went from room to room in hotels, looking for foreigners. By mid-afternoon, they had taken a Swiss Red Cross worker, two Australian teachers, two French medical workers and three journalists _ one French and two South Korean, Palestinian and foreign officials said.
Also kidnapped were a Canadian aid worker and an American professor at the American University in the West Bank town of Jenin.
The American professor, Douglas Johnson, said he was unharmed and understood his abductors' actions.
"They are angry over what is going on in Jericho. I feel sympathy with them," he told an Associated Press reporter at an abandoned cemetery where he was briefly held before being freed.
Palestinian security took some foreigners, including an AP photographer, into protective custody, while others found their own way to security headquarters.
Masked Palestinian security agents entered the AP office in Gaza City and instructed the photographer to collect his belongings. Speeding through Gaza streets, they took him to preventive security headquarters before escorting him and about 15 other foreigners to a crossing point with Israel.
Armed militants easily overpowered Palestinian police on their way to vandalizing Western aid agencies.
Gunmen burst into a British cultural center in the Gaza Strip and after a brief shootout with Palestinian police, torched the building, then shot at Palestinian fire engines, hampering efforts to put out the flames, witnesses said. There were no reports of casualties.
Militants also stormed the offices of AMIDEAST, a private American organization that provides English classes and academic testing services. The rioters broke windows and beat a Palestinian employee who tried to stop them.
"We don't want to see any Americans here," one of the gunmen shouted when Palestinian police approached the office.
In Gaza City, a crowd stormed empty European Union offices, smashing windows and replacing the EU flag with a militant banner. Some of the intruders shouted: "Death to the Americans, death to the British."
In the West Bank, dozens of Palestinians occupied the local British Council office, which had been evacuated.
Foreign journalists, from left, Korean Yong Tae-young, 41, a correspondent for public broadcaster KBS, SIPA agency photographer Alfred Yacobzadeh and French national Caroline Laurent, a correspondent for Elle magazine, are held by Palestinian gunmen from the Popular Front for the Liberation of Palestine in Khan Yunis refugee camp, southern Gaza Strip, Tuseday, March 14, 2006. Nine foreign nationals were kidnapped in protest against an Israeli raid of a West Bank prison. (AP Photo)
Palestinian police whisked foreigners to safety, and several international relief agencies closed in the Palestinian territories on Tuesday in response to the kidnapping of aid workers and journalists by angry militants.
Gunmen abducted 10 journalists and aid workers and vandalized offices linked to the U.S. and Britain, in the most violent campaign against foreigners in recent memory in the Palestinian territories. The mayhem was prompted by Israel's raid on a West Bank prison and seizure of a Palestinian militant leader and his accomplices in the assassination of an Israeli Cabinet minister.
Frightened foreigners sought refuge at Palestinian security headquarters, and a U.N. jeep came under fire as it tried to leave the coastal strip. Angry Palestinians accused Britain and the U.S. of complicity in Israel's siege of the prison.
By the end of the day, all but three of the kidnapped foreigners were freed.
The fury hit aid groups and organizations that have been working to alleviate the grinding poverty Palestinians face in Gaza, and it threatened to disrupt relief efforts.
"The European Commission deplores the attacks on member states' offices. The first to suffer are the Palestinian people," said Johannes Laitenberger, spokesman for the European Union's executive office.
The outbreak of anti-foreigner violence was the second in recent weeks. Reacting to Danish cartoons disparaging the Prophet Muhammad, angry Palestinians stormed European buildings and briefly held some aid workers. The relief teams had just started returning to the coastal strip when Tuesday's violence sent them scurrying for safety again.
Several international aid agencies, including the United Nations Relief and Works Agency said they were temporarily pulling their staff out of the West Bank and Gaza.
Officials said U.N. operations would not be affected, as the 8,500 local Palestinian workers would remain on the job, while 13 foreign U.N. staffers were leaving the Palestinian areas.
The kidnappings started shortly after Israeli forces surrounded the Jericho prison, demanding the surrender of Ahmed Saadat, the leader of a radical PLO faction, and four of his alleged accomplices in the 2001 killing of an Israeli Cabinet minister. A sixth militant was being sought on other charges.
In Gaza, gunmen went from room to room in hotels, looking for foreigners. By mid-afternoon, they had taken a Swiss Red Cross worker, two Australian teachers, two French medical workers and three journalists _ one French and two South Korean, Palestinian and foreign officials said.
Also kidnapped were a Canadian aid worker and an American professor at the American University in the West Bank town of Jenin.
The American professor, Douglas Johnson, said he was unharmed and understood his abductors' actions.
"They are angry over what is going on in Jericho. I feel sympathy with them," he told an Associated Press reporter at an abandoned cemetery where he was briefly held before being freed.
Palestinian security took some foreigners, including an AP photographer, into protective custody, while others found their own way to security headquarters.
Masked Palestinian security agents entered the AP office in Gaza City and instructed the photographer to collect his belongings. Speeding through Gaza streets, they took him to preventive security headquarters before escorting him and about 15 other foreigners to a crossing point with Israel.
Armed militants easily overpowered Palestinian police on their way to vandalizing Western aid agencies.
Gunmen burst into a British cultural center in the Gaza Strip and after a brief shootout with Palestinian police, torched the building, then shot at Palestinian fire engines, hampering efforts to put out the flames, witnesses said. There were no reports of casualties.
Militants also stormed the offices of AMIDEAST, a private American organization that provides English classes and academic testing services. The rioters broke windows and beat a Palestinian employee who tried to stop them.
"We don't want to see any Americans here," one of the gunmen shouted when Palestinian police approached the office.
In Gaza City, a crowd stormed empty European Union offices, smashing windows and replacing the EU flag with a militant banner. Some of the intruders shouted: "Death to the Americans, death to the British."
In the West Bank, dozens of Palestinians occupied the local British Council office, which had been evacuated.
