Impurities Guidelines

Permissible limits for impurities during clinical development has always been a grey area. Existing guidelines, specifically ICH Q3A only formally apply to marketed products.  How factors such as duration of clinical trials have never been effectively addressed.  A new paper looks in depth at how limits for impurities can be effectively linked to duration.  It is hoped this will have a significant positive impact, that durationally adjusted limits will  significantly reduce unnecessary toxicity studies and also unnecessary material reprocessing.