Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
FDA evaluations using in vitro metabolism to predict and interpret in vivometabolic drug-drug interactions: Impact on labeling
Autore:
Davit, B; Reynolds, K; Yuan, R; Ajayi, F; Conner, D; Fadiran, E; Gillespie, B; Sahajwalla, C; Huang, SM; Lesko, LJ;
Indirizzi:
US FDA, Off Clin Pharmacol & Biopharmaceut, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Rockville, MD 20852 USA US FDA Rockville MD USA 20852 Drug Evaluat & Res, Rockville, MD 20852 USA
Titolo Testata:
JOURNAL OF CLINICAL PHARMACOLOGY
fascicolo: 9, volume: 39, anno: 1999,
pagine: 899 - 910
SICI:
0091-2700(199909)39:9<899:FEUIVM>2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Soggetto:
IMMUNODEFICIENCY-VIRUS PROTEASE; HUMAN LIVER-MICROSOMES; REUPTAKE-INHIBITOR ANTIDEPRESSANTS; HUMAN CYTOCHROMES P450; IN-VITRO; P-GLYCOPROTEIN; CLINICAL PHARMACOKINETICS; WARFARIN-FLUCONAZOLE; ALPRAZOLAM; RITONAVIR;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
63
Recensione:
Indirizzi per estratti:
Indirizzo: Huang, SM US FDA, Off Clin Pharmacol & Biopharmaceut, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, HFD 850,WOC 2,Room 3016,1451 Rockville Pike, Rockville, MD 20852 USA US FDA HFD 850,WOC 2,Room 3016,1451 Rockville Pike Rockville MD USA 20852
Citazione:
B. Davit et al., "FDA evaluations using in vitro metabolism to predict and interpret in vivometabolic drug-drug interactions: Impact on labeling", J CLIN PHAR, 39(9), 1999, pp. 899-910

Abstract

Recent advances in in vitro metabolism methods have led to an improved ability to predict clinically relevant metabolic drug-drug interactions. To address the relationships of in vitro metabolism data and in vivo metabolism outcomes, the Office of Clinical Pharmacology and Biopharmaceutics in the Center for Drug Evaluation and Research, Food and Drug Administration, evaluated a number of recently approved new drug applications. The goal of theseevaluations was to determine the contribution of in vitro metabolism data in (1) predicting in vivo drug-drug interactions, (2) determining the need to conduct on in vivo drug-drug interaction study, and (3) incorporating findings into drug product labeling. Ten cases are presented in this article. They fall into two major groups: (1) in vitro data were predictive of in vivo results, and (2) in vitro data were not predictive of in vivo results. Discussion of these cases highlights factors limiting predictability of in vivo metabolic interactions fi om in vitro metabolism data. The integrationof these findings into drug product labeling is also discussed. Journal ofClinical Pharmacology 1999;39:899-910 (C) 1999 the American College of Clinical Pharmacology.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 06/07/20 alle ore 07:54:46