Advances in bioequivalence of narrow therapeutic index drugs

Abstract

Abstract:

In recent years, the evaluation of the bioequivalence (BE) of narrow therapeutic index (NTI) drugs has drawn much attention. Yet,there are still some controversial issues unresolved about how to evaluate the BE of NTI drugs . Currently in China,there is no relevant guideline for the BE studies of NTI drugs . This article introduces and analyzes the difficulties and major solutions to the BE study of NTI drugs. By referring to the domestic and foreign laws, guidelines and related literature, the BE evaluation of NTI drugs and reference-scaled average bioequivalence(RSABE) methods are introduced in hope of providing reference and help for the evaluation of generic drug quality and efficacy of narrow treatment index drugs in China.

Key words: narrow therapeutic index (NTI) drugs, bioequivalence, reference-scaled average bioequivalence (RSABE)

CLC Number:

R969.1

XU Maodi，WU Zijing， XIE Haitang. Advances in bioequivalence of narrow therapeutic index drugs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics.

References

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