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Special Populations and Evidence of Safety and Efficacy for Drug Registration

  • Marc Bogaert
Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)

Abstract

Every patient presents individual characterisitics, and the dosage of a drug has to be adapted according to the pharmacokinetics and pharmacodynamics in that patient. It is therefore somewhat misleading to talk about dosage requirements in the “average adult”. From a practical point of view it is however necessary to define such an average dosage requirement. Still, one has to be aware that the dosage has to be adapted according to the characteristics of the individual patient and to the response to the starting dose.

Keywords

Special Population Special Group Drug Application Package Insert Average Adult 
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

© Springer Science+Business Media New York 1981

Authors and Affiliations

  • Marc Bogaert
    • 1
  1. 1.Heymans Institute of PharmacologyUniversity of Gent Medical SchoolGentBelgium

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