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Titolo:
THE USE OF POPULATION PHARMACOKINETICS IN DRUG DEVELOPMENT
Autore:
VOZEH S; STEIMER JL; ROWLAND M; MORSELLI P; MENTRE F; BALANT LP; AARONS L;
Indirizzi:
UNIV GENEVA,DEPT PSYCHIAT,CLIN RES UNIT,47 RUE 31 DECEMBRE CH-1207 GENEVA SWITZERLAND UNIV GENEVA,DEPT PSYCHIAT,CLIN RES UNIT CH-1207 GENEVA SWITZERLAND INTERCANTONAL OFF CONTROL MED BERN SWITZERLAND F HOFFMANN LA ROCHE,DEPT CLIN PHARMACOL BASEL SWITZERLAND UNIV MANCHESTER,DEPT PHARM MANCHESTER M13 9PL LANCS ENGLAND UNIV BARCELONA,DEPT CLIN PHARMACOL,HOP TRIAS & PUJOL BADALONA SPAIN CHU PITIE SALPETRIERE,INSERM U436 PARIS FRANCE
Titolo Testata:
Clinical pharmacokinetics
fascicolo: 2, volume: 30, anno: 1996,
pagine: 81 - 93
SICI:
0312-5963(1996)30:2<81:TUOPPI>2.0.ZU;2-2
Fonte:
ISI
Lingua:
ENG
Soggetto:
ROUTINE CLINICAL-DATA; MAXIMUM-LIKELIHOOD-ESTIMATION; PARAMETER-ESTIMATION; THERAPEUTIC TRIALS; PLASMA-CONCENTRATIONS; PHARMACODYNAMIC MODEL; INTRAVENOUS-INFUSION; NONMEM ANALYSIS; PHENYTOIN; THEOPHYLLINE;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
180
Recensione:
Indirizzi per estratti:
Citazione:
S. Vozeh et al., "THE USE OF POPULATION PHARMACOKINETICS IN DRUG DEVELOPMENT", Clinical pharmacokinetics, 30(2), 1996, pp. 81-93

Abstract

Currently, there is an increasing focus on the implementation of pharmacokinetic-pharmacodynamic (PK-PD) studies and modelling as essentialtools for drug development. Strategies involving specifically the population approach, which are based on relatively recent statistical methodology (e.g. nonlinear mixed effects modelling, NONMEM) have been advocated for investigating pharmacokinetic and pharmacodynamic variability as well as dose-concentration-effect relationships. The present article outlines this approach, and discusses how it can be implemented within the framework of the studies currently performed as part of theclinical phases of new drug development. It also considers study design and performance, based on real-life experiences. Population approaches, if designed carefully and early, as part of the planning of the drug development programme, are expected to play a significant role at every phase of the programme and to contribute to providing information that is valuable for registration purposes. Statistical methodology and software are now widely available. However, practical issues such as integration of the population approach within existing protocols, quality control of the data, timing of laboratory and statistical analyses, as well as resource allocation, remain legitimate concerns to be considered in prospective studies.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/09/20 alle ore 11:32:23