手性药物的研发与注册。

Development and registration of chiral drugs.

作者信息

Witte D T, Ensing K, Franke J P, De Zeeuw R A

机构信息

Department of Analytical Chemistry and Toxicology, University Centre for Pharmacy, Groningen, The Netherlands.

出版信息

Pharm World Sci. 1993 Feb 19;15(1):10-6. doi: 10.1007/BF02116164.

DOI:10.1007/BF02116164

PMID:8485501

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.

摘要

在本综述中，我们描述了手性对美国、日本和欧盟药品研发及注册的影响。对映体在药理特性上可能存在差异，因此，手性药物在研发过程中需要特别的分析和药理关注。然而，注册管理机构对于手性药物的注册并没有明确的政策。缺乏关于手性的明确政策在各个层面上造成了极大的混乱和挫败感，并且不利于开发更新型、更有益药物的行业。