Common narrow therapeutic index drugs and the current status of bioequivalence evaluation

doi:10.12092/j.issn.1009-2501.2019.10.016

Abstract

Abstract:

There are still some blind areas in bioequivalence evaluation of narrow therapeutic index (NTI) drugs so far and no relevant guideline is issued in China. The bioequivalence requirements of NTI drugs are variable among the main international regulations, and there is no global unified NTI drugs list. In addition, for some particular NTI drugs, different equivalence limits are accepted in different regulatory regions. Based on domestic and foreign regulations, guidelines and related literature, through analyzing the status of several fundamental NTI drugs and the bioequivalence studies, we hope to contribute to the conduction of bioequivalence study in the future and to help the development of bioequivalence guideline of NTI drugs in China.

Key words: narrow therapeutic index drugs, bioequivalence, equivalence limit

CLC Number:

R541
R969

CHEN Xiaoping, HU Chaoying, ZHANG Lan. Common narrow therapeutic index drugs and the current status of bioequivalence evaluation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2019, 24(10): 1188-1193.

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