Genotoxic impurities in pharmaceutical products – regulatory, toxicological and pharmaceutical considerations

oleh: Katarzyna Regulska, Marcin Michalak, Marek Murias, Beata Stanisz

Format: Article
Diterbitkan: Poznan University of Medical Sciences 2021-03-01

Deskripsi

This article provides an overview of the most important aspects around the detecting and reporting of genotoxic impurities in the pharmaceutical industry. It focuses on relevant regulatory, toxicological, and pharmaceutical considerations. In this regard, the concept of Threshold of Toxicological Concern is explained and the most common genotoxic impurities are described. Furthermore, toxicological methods for genotoxic impurities screening are presented. Finally, the article emphasises several issues regarding further development.