Ecotoxicological assessment of pharmaceuticals and personal care products using predictive toxicology approaches

With their widespread and ever increasing use, active pharmaceutical ingredients (API) and personal care products (PCP) represent contaminants of emerging […]

Mutagenicity assessment of drug impurities according to the ICH M7 (R1) guideline and the role of expert review

The evaluation of the genotoxicity potential of drug impurities has been the focus of regulatory recommendations issued by the United States Food and Drug Administration (FDA, 2008), European Medicines Agency (EMA, 2006 and 2010), and International Conference for Harmonization (ICH, 2014, 2015). In 2017, the ICH M7 issued a revised guideline providing a framework for the assessment and control of mutagenic impurities in pharmaceuticals.

Dr. Francesca Tencalla

New Approach Methodologies