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Clinical Pharmacokinetics

, Volume 30, Issue 2, pp 81–93 | Cite as

The Use of Population Pharmacokinetics in Drug Development

  • Samuel Vozeh
  • Jean-Louis Steimer
  • Malcolm Rowland
  • Paolo Morselli
  • France Mentré
  • Luc P. BalantEmail author
  • Leon Aarons
Current Opinion

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.

Keywords

Drug Development Population Approach Tacrine Population Pharmacokinetic Tianeptine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis International Limited 1996

Authors and Affiliations

  • Samuel Vozeh
    • 1
  • Jean-Louis Steimer
    • 2
  • Malcolm Rowland
    • 3
  • Paolo Morselli
    • 4
  • France Mentré
    • 5
  • Luc P. Balant
    • 6
    Email author
  • Leon Aarons
    • 3
  1. 1.Intercantonal Office for the Control of MedicinesBernSwitzerland
  2. 2.Department of Clinical PharmacologyF. Hoffmann-La RocheBaselSwitzerland
  3. 3.Department of PharmacyUniversity of ManchesterManchesterEngland
  4. 4.Buc, France, and Department of Clinical PharmacologyUniversity of Barcelona, Hopital Trias i PujolBadalonaSpain
  5. 5.CHU Pitié-SalpétrièreINSERM U436ParisFrance
  6. 6.Clinical Research Unit, Department of PsychiatryUniversity of GenevaGenèveSwitzerland

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