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

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.