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Titolo:
PRACTICAL EXPERIENCE AND ISSUES IN DESIGNING AND PERFORMING POPULATION PHARMACOKINETIC PHARMACODYNAMIC STUDIES/
Autore:
AARONS L; BALANT LP; MENTRE F; ROWLAND M; STEIMER JL; VOZEH S;
Indirizzi:
UNIV MANCHESTER,DEPT PHARM,OXFORD RD MANCHESTER M13 9PL LANCS ENGLAND UNIV GENEVA,DEPT PSYCHIAT,CLIN RES UNIT GENEVA SWITZERLAND CHU PITIE SALPETRIERE,INSERM,U436 PARIS FRANCE UNIV AUTONOMA BARCELONA,HOSP TRIAS & PUJOL,DEPT CLIN PHARMACOL BARCELONA SPAIN SANDOZ PHARMA AG BASEL SWITZERLAND OFF INTERCANTONAL CONTROLE MEDICAMENTS BERN SWITZERLAND
Titolo Testata:
European Journal of Clinical Pharmacology
fascicolo: 4, volume: 49, anno: 1996,
pagine: 251 - 254
SICI:
0031-6970(1996)49:4<251:PEAIID>2.0.ZU;2-L
Fonte:
ISI
Lingua:
ENG
Keywords:
POPULATION PHARMACOKINETICS,; PHARMACODYNAMICS, EXPERIMENTAL DESIGN, DRUG DEVELOPMENT, CLINICAL TRIALS;
Tipo documento:
Editorial Material
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
1
Recensione:
Indirizzi per estratti:
Citazione:
L. Aarons et al., "PRACTICAL EXPERIENCE AND ISSUES IN DESIGNING AND PERFORMING POPULATION PHARMACOKINETIC PHARMACODYNAMIC STUDIES/", European Journal of Clinical Pharmacology, 49(4), 1996, pp. 251-254

Abstract

An expert meeting to discuss issues relating to the design of population pharmacokinetic/pharmacodynamic (PK/PD) studies was held in Brussels in March 1995, under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. The purpose of the meeting was to discuss the experts' experience in designing and performing population PK/PD studies. The topics discussed were current practice, logistical issues, ensuring the accuracy of data, covariate assessment, communication, and protocol design. The main conclusions from the meeting were: 1) a population PK/PD analysis should be one of the objectives of a clinical trial and should not compromise the other objectives; 2) it is particularly important to communicate the purposeof the population PK/PD analysis to the investigators and to convincethem of the importance of accurately recording dosing and sampling times; 3) some prior knowledge of the PK and PD models and covariate relationships is necessary for the analysis of sparse phase III data; 4) computer simulation and optimal design measures may be useful in defining sampling times; 5) population methods and objectives must be specified as completely as possible in the protocol.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/09/20 alle ore 12:46:52