Management of Genotoxic Impurities in Pharmaceuticals With the Threshold of Toxicological Concern.
- Resource Type
- Article
- Authors
- McGovern, Timothy J.
- Source
- International Journal of Toxicology (Sage). 2010, Vol. 29 Issue 1, p131-131. 1/4p.
- Subject
- Language
- ISSN
- 1091-5818
Safety concerns regarding known or suspected genotoxic impurities in pharmaceutical products have become more prominent in the last decade. When regulators identified concerns, delays often occurred in pharmaceutical development programs, at least partially due to the lack of consistent regulatory guidance. The Committee for Medicinal Products for Human Use (CHMP) of the EMEA and the Center for Drug Evaluation and Research (CDER) of the US FDA subsequently released guidance (final and draft, respectively) on how best to deal with these impurities in 2006 and 2008. The recommendations include the use of toxicological thresholds as one acceptable approach for setting acceptable daily exposure levels. The recommended thresholds are based on a previous Threshold of Regulation approach developed by US FDA’s Center for Food Safety and Nutrition for food contact materials set on the determination of a virtually safe dose derived from a carcinogenic potency data base. This session will discuss the derivation of the TTC by the CHMP and CDER and will describe how the TTC is applied to the regulation of genotoxic impurites in pharmaceutical products. [ABSTRACT FROM AUTHOR]