Pharmacy World and Science

, Volume 15, Supplement 1, pp 10–16

Development and registration of chiral drugs

  • Dirk T. Witte
  • Kees Ensing
  • Jan-Piet Franke
  • Rokus A. De Zeeuw
Reviews

DOI: 10.1007/BF02116164

Cite this article as:
Witte, D.T., Ensing, K., Franke, JP. et al. Pharm World Sci (1993) 15(Suppl 1): 10. doi:10.1007/BF02116164

Abstract

In this review we describe the impact of chirality on drug development and registration in the United States, Japan and the European Community. Enantiomers may have differences in their pharmacological profiles, and, therefore, chiral drugs ask for special analytical and pharmacological attention during their development. However, the registration authorities have no clear policy towards the registration of chiral drugs. The absence of a clear policy regarding chirality causes a great deal of confusion and frustration at various levels and is not in the interest of industries developing newer and more beneficial drugs.

Keywords

Chemisty, analyticalDiastereoisomersDrug designEnantiomersEuropean CommunityJapanPharmacologyRacematesRegistration, drugsStereoisomersUnited States Food and Drug Administration

Copyright information

© Periodicals Service Company 1993

Authors and Affiliations

  • Dirk T. Witte
    • 1
  • Kees Ensing
    • 1
  • Jan-Piet Franke
    • 1
  • Rokus A. De Zeeuw
    • 1
  1. 1.Department of Analytical Chemistry and ToxicologyUniversity Centre for PharmacyAW Groningenthe Netherlands