Population approaches in drug development. Report on an expert meeting to discuss population pharmacokinetic/pharmacodynamic software.

Abstract:

:An expert meeting to discuss population pharmacokinetic/pharmacodynamic software was held in Brussels in November 1993 under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. Recently developed statistical methods offer the possibility of gaining integrated information on pharmacokinetics and response from relatively sparse observational data obtained directly in patients who are being treated with the drug under development. These methods can minimize the need to exclude patient groups and also allow analysis of a variety of unbalanced designs that frequently arise in the evaluation of the relationships between dose or concentration on the one hand and efficacy or safety on the other relationships that do not readily lend themselves to other forms of statistical analysis. The purpose of the Brussels meeting was to evaluate the state of both existing software and software under development, and to specify the needs and wishes of potential users of such software. It was apparent from the meeting that software development for population data analysis is currently a very active area of investigation and that several very good packages are already available, with more in development. The general consensus of the meeting was that well validated, easy to use software was essential to the implementation of the population approach to drug development.

journal_name

Eur J Clin Pharmacol

authors

Aarons L,Balant LP,Mentré F,Morselli PL,Rowland M,Steimer JL,Vozeh S

doi

10.1007/BF00191898

subject

Has Abstract

pub_date

1994-01-01 00:00:00

pages

389-91

issue

5

eissn

0031-6970

issn

1432-1041

journal_volume

46

pub_type

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