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Inter-ethnic differences in dose-response studies

  • Luc P. Balant
  • Pierre Bechtel
Part of the CMR Workshop Series book series (CMRW)

Summary

  1. 1.

    Currently, it is unclear how frequent or widespread genetic differences are with respect to drug metabolism nor is it always apparent how these differences are influenced by culture, lifestyle or choice of foods. Therefore, questions are raised as to what are the medical and toxicological consequences of these ethnic differences

     
  2. 2.

    Inter-ethnic investigations in Phase I and II studies should provide information on dose-concentration-response relationships. The overall benefit of these investigations of pharmacokinetics and pharmacodynamics in both preclinical and clinical studies can produce an early identification of optimal dosing regimens thus shortening the overall time for drug development

     
  3. 3.

    If in vitro data obtained with human microsomes or human hepatocytes indicate that the metabolism of a new compound might be under the control of a known genetic polymorphism, it is now well accepted that the first studies in healthy volunteers should ideally be performed in a panel consisting both of extensive and poor metabolisers. If the difference between the two groups shows potential clinical significance, special care must be taken in the development of the new compound. If the contrary is true, drug development may generally proceed without this requirement

     
  4. 4.

    However, if a drug product is developed involving essentially healthy subjects and patients of a single racial group and if the product is to be commercialised in a geographic area where another racial group is predominant, some precautions must be taken as far as safety and efficacy are concerned

     

Keywords

Drug Development Drug Metabolism Poor Metabolisers Extensive Metabolisers Potential Clinical Significance 
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 Dordrecht 1994

Authors and Affiliations

  • Luc P. Balant
  • Pierre Bechtel

There are no affiliations available

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