ISSN:
1432-1041
Keywords:
Key words Population pharmacokinetics
;
Pharmacodynamics; experimental design
;
drug development
;
clinical trials
Source:
Springer Online Journal Archives 1860-2000
Topics:
Chemistry and Pharmacology
,
Medicine
Notes:
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 purpose of the population PK/PD analysis to the investigators and to convince them 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.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1007/BF00226323
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