Springer - Global Approach in Safety Testing: ICH Guidelines

Gain a deeper understanding of pharmaceutical safety standards with Global Approach in Safety Testing: ICH Guidelines Explained. As part of the AAPS Advances in the Pharmaceutical Sciences Series, this volume focuses on the major ICH category of Safety. It provides necessary context for in vitro and in vivo pre-clinical studies, including vital topics like Carcinogenicity Testing and Genotoxicity Testing. While many ICH guidelines exist, this book fills a significant gap by providing the background and expert reasoning that formal Congresses often omit. It moves beyond the written text to explore the thoughts of the experts who shaped these documents. By answering why specific guidelines were written in their current form, this resource helps professionals understand the logic behind the regulatory requirements. This is an essential addition for those working in pharmacy, drug development, and pharmaceutical sciences who need to understand the foundation of safety testing protocols.