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Titolo:
Workshop on bioanalytical methods validation for macromolecules: Summary report
Autore:
Miller, KJ; Bowsher, RR; Celniker, A; Gibbons, J; Gupta, S; Lee, JW; Swanson, SJ; Smith, WC; Weiner, RS;
Indirizzi:
Amgen Inc, Pharmacokinet & Drug Metab, Thousand Oaks, CA 91320 USA Amgen Inc Thousand Oaks CA USA 91320 g Metab, Thousand Oaks, CA 91320 USA Eli Lilly & Co, Indianapolis, IN 46285 USA Eli Lilly & Co Indianapolis INUSA 46285 & Co, Indianapolis, IN 46285 USA Wyeth Ayerst Res, Genet Inst, Andover, MA 01810 USA Wyeth Ayerst Res Andover MA USA 01810 , Genet Inst, Andover, MA 01810 USA Jacqueline Gibbons Consulting, Piedmont, CA 94611 USA Jacqueline Gibbons Consulting Piedmont CA USA 94611 iedmont, CA 94611 USA Amgen Inc, Clin Immunol, Thousand Oaks, CA 91320 USA Amgen Inc Thousand Oaks CA USA 91320 Immunol, Thousand Oaks, CA 91320 USA MDS Pharma Serv, Lincoln, NE USA MDS Pharma Serv Lincoln NE USAMDS Pharma Serv, Lincoln, NE USA Bristol Myers Squibb Co, New Brunswick, NJ 08903 USA Bristol Myers Squibb Co New Brunswick NJ USA 08903 runswick, NJ 08903 USA Univ Utrecht, NET, Utrecht, Netherlands Univ Utrecht Utrecht Netherlands niv Utrecht, NET, Utrecht, Netherlands Washington Univ, St Louis, MO 63130 USA Washington Univ St Louis MO USA 63130 ington Univ, St Louis, MO 63130 USA Proctor & Gamble Pharmaceut, Mason, OH 45040 USA Proctor & Gamble Pharmaceut Mason OH USA 45040 aceut, Mason, OH 45040 USA Pharmacia Corp, Skokie, IL 60077 USA Pharmacia Corp Skokie IL USA 60077Pharmacia Corp, Skokie, IL 60077 USA Roche Mol Syst, Pleasanton, CA 94588 USA Roche Mol Syst Pleasanton CA USA94588 Mol Syst, Pleasanton, CA 94588 USA MedImmune Inc, Frederick, MD 21703 USA MedImmune Inc Frederick MD USA 21703 dImmune Inc, Frederick, MD 21703 USA Pharmacia & Upjohn Inc, Kalamazoo, MI 49007 USA Pharmacia & Upjohn Inc Kalamazoo MI USA 49007 nc, Kalamazoo, MI 49007 USA Warner Lambert Parke Davis, Ann Arbor, MI 48105 USA Warner Lambert Parke Davis Ann Arbor MI USA 48105 Ann Arbor, MI 48105 USA Phoenix Int Life Sci, St Laurent, PQ H4R 2N6, Canada Phoenix Int Life SciSt Laurent PQ Canada H4R 2N6 ent, PQ H4R 2N6, Canada Glaxo Wellcome Inc, Res Triangle Pk, NC 27709 USA Glaxo Wellcome Inc Res Triangle Pk NC USA 27709 Triangle Pk, NC 27709 USA PPD Dev, Richmond, VA 23230 USA PPD Dev Richmond VA USA 23230PPD Dev, Richmond, VA 23230 USA
Titolo Testata:
PHARMACEUTICAL RESEARCH
fascicolo: 9, volume: 18, anno: 2001,
pagine: 1373 - 1383
SICI:
0724-8741(200109)18:9<1373:WOBMVF>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
WASHINGTON CONFERENCE; BIOAVAILABILITY; BIOEQUIVALENCE; IMMUNOASSAYS;
Keywords:
bioanalytical methods validation; macromolecules; ligand-binding assay; immunoassays; ELISA; EIA; RIA; anti-drug; bioassay; biomarker; total error; assays; quality control; acceptance criteria; specificity; accuracy; precision; recovery; calibration; drug development; neutralizing antibody;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
14
Recensione:
Indirizzi per estratti:
Indirizzo: Miller, KJ Amgen Inc, Pharmacokinet & Drug Metab, 1 Amgen Ctr Dr 1-1-B, Thousand Oaks, CA 91320 USA Amgen Inc 1 Amgen Ctr Dr 1-1-B Thousand Oaks CA USA 91320 0 USA
Citazione:
K.J. Miller et al., "Workshop on bioanalytical methods validation for macromolecules: Summary report", PHARM RES, 18(9), 2001, pp. 1373-1383


ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 09/07/20 alle ore 16:51:46