Preliminary discussion on evaluation of bioequivalence for highly variable drugs and drug products

Abstract

Abstract: The evaluation of bioequivalence (BE) for highly variable drugs and drug products is an important issue with much concern by industry and regulatory agencies.In this article the authors analyze the difficulties in proving BE when the intrasubject variability is high and introduce several approaches to solve them.The perspectives and suggestions may be very helpful for the domestic BE investigators to focus on this problem and practise more rationally and scientifically.

Key words: highly-variable drugs, bioequivalence, evaluation

CLC Number:

R969

HUANG Qin, WEI Chun-min. Preliminary discussion on evaluation of bioequivalence for highly variable drugs and drug products[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2007, 12(8): 841-844.

References

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