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

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

  1. 1、本文档共1页,可阅读全部内容。
  2. 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
  3. 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载
  4. 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
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

您可能关注的文档

文档评论(0)

千年硕鼠 + 关注
实名认证
内容提供者

药学医师证持证人

10年深耕医疗器械、体外诊断试剂领域

版权声明书
用户编号:5014214200000130
领域认证该用户于2023年05月20日上传了药学医师证

1亿VIP精品文档

相关文档