M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes(Draft)(M7（R1）ICH M7附录：评估和控制药物中的DNA反应性（致突变）杂质，以限制潜在致癌风险；应用ICH M7指导原则计算化合物特定可接受摄入量（草案）)