10.生物制品稳定性研究技术指导原则（试行）（20150415）

11.生物制品生产工艺过程变更管理技术指导原则（20080904）

12.生物制品质量控制分析方法验证技术一般原则（20080904）

13.治疗用生物制品非临床安全性技术审评一般原则（20100506）

14.药物Ⅰ期临床试验管理指导原则（试行）（20111207）

15.ICH Q3A（R2）-Impurities in new drug substances.

16.ICH Q3B（R2）- Impurities in new drug Products.

17.ICH E6（R1）-Guideline for good clinical practice.

18.ICH E6（R2）-Integrated addendum to ICH E6（R1）

19.ICH M3（R2）-Guidance on nonclinical safety studies for the conduct of human clinical trails and marketing authorization for pharmaceuticals.

20.ICH M4- The Common Technical Document.

21.ICH M7（R1）-Assessment and control of DNA reactive（mutagenic）impurities in pharmaceuticals to limit potential carcinogenic risk.

22.ICH S6-Preclinical safety evaluation of biotechnology derived pharmaceuticals.

23.ICH S9 -Nonclinacal evaluation for anticancer pharmaceuticals.

24.Content and format of INDs for phase I studies of drugs,including well-characterized, therapeutic, biotechnology-derived products.

25.Guidance for Industry Q&A on Content and format of INDs for phase I studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

原标题：初识：创新药I期临床申请须要研究的“药理-毒理”内容！