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The Use of Population Pharmacokinetics in Drug Development

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Summary

Currently, there is an increasing focus on the implementation of pharmacokinetic-pharmacodynamic (PK-PD) studies and modelling as essential tools 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 the clinical 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.

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Authors and Affiliations

  1. Intercantonal Office for the Control of Medicines, Bern, Switzerland

    Samuel Vozeh

  2. Department of Clinical Pharmacology, F. Hoffmann-La Roche, Basel, Switzerland

    Jean-Louis Steimer

  3. Department of Pharmacy, University of Manchester, Manchester, England

    Malcolm Rowland & Leon Aarons

  4. Buc, France, and Department of Clinical Pharmacology, University of Barcelona, Hopital Trias i Pujol, Badalona, Spain

    Paolo Morselli

  5. CHU Pitié-Salpétrière, INSERM U436, Paris, France

    France Mentré

  6. Clinical Research Unit, Department of Psychiatry, University of Geneva, 47, rue du XXXI Décembre, CH-1207, Genève, Switzerland

    Luc P. Balant

Authors
  1. Samuel Vozeh
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  2. Jean-Louis Steimer
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  3. Malcolm Rowland
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  4. Paolo Morselli
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  5. France Mentré
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  6. Luc P. Balant
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  7. Leon Aarons
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Corresponding author

Correspondence to Luc P. Balant.

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The names of the authors are deliberatcly given in reverse alphabetical order.

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Vozeh, S., Steimer, JL., Rowland, M. et al. The Use of Population Pharmacokinetics in Drug Development. Clin-Pharmacokinet 30, 81–93 (1996). https://doi.org/10.2165/00003088-199630020-00001

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