Exposure Based Limits for Controlling Impurities

摘要

Introduction: Whereas, the use of medicinal products is always a compromise between acceptable risks and likely benefits, the same is not true, for impurities. However, it is widely accepted that complex, multi-stage drug substances cannot be manufactured without the commensurate formation of impurities or degradation products. The compromise is to develop control strategies whereby these impurities can be controlled to appropriate safety based levels.