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| 基于美国FDA近五年批准的新药浅谈ICH S1指导原则的实施 |
| Implementation of ICH S1 guidelines based on a retrospective analysis of approved new drugs by FDA over the past five years |
| 投稿时间：2019-08-07 修订日期：2019-10-28 |
| DOI： |
| 中文关键词: 致癌性试验 ICH S1 致癌性试验必要性 剂量选择 Tg.rasH2小鼠 |
| 英文关键词: carcinogenicity test ICH S1 necessity of carcinogenicity test dose selection Tg.rasH2 mice |
| 基金项目:国家“重大新药创制”科技重大专项资助项目( 2018ZX09201-017) |
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| 中文摘要: |
| 致癌性研究是药物非临床安全性评价的重要内容之一，致癌性试验实施的复杂程度远远超出指导原则的要求。本文对美国FDA在2014~2018年五年期间批准的213个新药进行了一一梳理和分析，并结合ICH S1要求、文献报道和我们的实际工作经验，从致癌性试验的必要性、致癌性试验结果提交时间、生物制品致癌性试验的决策、致癌性试验的试验类型选择、致癌性试验的剂量设计等几方面提出意见和建议，力求为国内同行、新药研发企业和审评机构提供一些参考。 |
| 英文摘要: |
| The carcinogenicity test is one of the important components of drug nonclinical safety evaluations. The complexity of the carcinogenicity test far exceeds the requirements of the technical guidance of the government authorities. This article tried to summarized and analyze 213 drugs that have been approved by US FDA during the five-year period from 2014 to 2018, following the requirements of ICH S1, and based on our own experience in JOINN Labs and the published literature, some comments are provided, including the necessity of carcinogenicity test, the timing of submission of carcinogenic study results, the decision of biological carcinogenic test, the selection of study type for carcinogenicity tests and the dose selection of carcinogenicity test. We hope that our practical experience and the archive review could benefit the domestic industry, sponsors and the regulatory agency in China. |
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