This book provides an overview of the nonclinical testing strategies that are used to asses and
de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a
review of relevant ICH guidelines numerous case studies where follow-up studies were conducted
to further investigate positive findings and practical considerations for the use of
alternative and emerging tests. With contributions from recognized experts in the
pharmaceutical industry and health authorities this volume presents a balanced view on the
interpretation and application of genotoxicity and carcinogenicity regulatory guidances.
Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for
scientists regulators and consultants that are engaged in the conduct reporting and review
of nonclinical studies. This book will also help academicians better understand and appreciate
the complexity of the regulations and breadth of toxicology research that are necessary to
support the development and marketing of new drugs.
