ICH S1B(R1) industry and regulatory best practice for confident carcinogenicity assessment
The ICH S1B(R1) addendum is a globally recognised guideline that introduces a weight-of-evidence (WoE) approach to assessing the carcinogenic potential of pharmaceuticals. It helps pharmaceutical organisations determine whether a two-year rat carcinogenicity study would provide additional insight into human safety. In this session, attendees heard directly from former regulatory and industry experts who contributed to […]