| 文件名称： | Final Concept Paper S1B(R1) Testing for Carcinogenicity of Pharmaceuticals |
| 发布机构： | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) | 发布日期： | 2024-01-31 |
| 简介/内容概述： | The ICH S1B(R1) addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original ICH S1B. This is an integrative approach that provides specific WoE criteria that inform whether a 2-year rat study is likely to add value to a human carcinogenicity risk assessment. This integrative approach reduces the use of animals in accordance with the 3R (reduce/refine/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments. |
