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Individuals vary widely in their response to standard dosages of drugs. Variability is seen in both pharmacokinetics and pharmacodynamics. The causes of this variability are many, and include genetics, disease, other drugs, age and environmental factors. Newly applied statistical methods now offer the possibility of gaining integrated information on pharmacokinetics and response from relatively sparse observational data obtained directly in the patient population requiring the drug under development. The potential benefits of these population approaches are great. However, the population approach is still in its infancy, with many statistical, ethical and logistical questions to be resolved. A two-day conference was held in Manchester, UK, which brought together leading academics, industrialists and regulatory scientists, concerned with the application of the population approach in drug development. They shared their experiences, identified the critical issues and discussed the potential applications and limitations of the approach. This document records their presentations and the ensuing discussion.

Additional information

Authors: ROWLAND M, CEC Bruxelles (BE);AARONS L, CEC Bruxelles (BE)
Bibliographic Reference: EUR 13775 EN (1992) 271 pp., FS, ECU 30
Availability: (2)
ISBN: ISBN 92-826-2959-7
Record Number: 199210505 / Last updated on: 1994-12-02
Original language: en
Available languages: en
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