ICH协调指导原则 M7：评估和控制药物中DNA反应性（致突变）杂质以限制潜在致癌风险 问答文件支持文件.pdf

3 June 2020 M7 QA Support Document Note: The following is an extract of the M7(R2) draft Guideline and is made available as a Support Document to the M7 QA question #7.4. The full M7(R2) draft Guideline will be made available for public consultation separately. Please refer to the ICH website for further information regarding the status of the M7(R2) draft Guideline. Note 7 Table 4: Examples of clinical use scenarios with different treatment durations for applying acceptable intakes 1 Scenario Acceptable Intake (µg/day) Treatment duration of 1 month: e.g., drugs used in emergency 120 procedures (antidotes, anesthesia, acute ischemic stroke), actinic keratosis, treatment of lice Treatment duration of 1-12 months: e.g., anti-infective therapy 20 with maximum up to 12 months treatment (HCV), parenteral nutrients, prophylactic flu drugs (~ 5 months), peptic ulcer, Assisted Reproductive Technology (ART), pre-term labor, preeclampsia, pre- surgical (hysterectomy) treatment, fracture healing (these are acute use but with long half-lives) Treatment duration of 1-10 years: e.g., stage of disease with 10 short life expectancy (severe Alzheimer’s), non-genotoxic anticancer treatment being used in a patient population with longer term survival (breast cancer, chronic myelogenous leukemia), d