A preliminary study on the ethical risk assessment of human bioequivalence trial

Abstract

Abstract:

Bioequivalence (BE) trail is an important index to evaluate the quality of the preparation. Due to a large number of listed drug efficacy and safety of data accumulation, the ethical risk is often ignored by the sponsor and ethics committee. This article lists specific cases to assess the additional ethical risks to health subjects in a human bioequivalence trial, including examining the drug brochure, racial differences, and the differences of adverse reactions between healthy and indications in hope of offering reference for controlling ethical risk in human equivalence trial.

Key words: ethical risk, human bioequivalence trial, abacavir, lenalidomide, isosorbide mononitrate, clozapine, imatinib

CLC Number:

R969.4

QIAN Wei, ZHENG Linhai, YANG Di, YE Fangqin, YANG Jin. A preliminary study on the ethical risk assessment of human bioequivalence trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(9): 1077-1080.

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