The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trial-Reference-Cited by-同舟云学术

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The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trial

Published:2013 Issue: Volume: Page:309-334
ISSN:
Container-title:A Comprehensive Guide to Toxicology in Preclinical Drug Development
language:
Short-container-title:

Author:

Nugent Paul,Duncan J. Neil,Colagiovanni Dorothy B.

Publisher

Elsevier

Reference38 articles.

1. ICH at 20: An Overview;Kuhnert;Global Forum,2011

2. The CTD: A tool for global development and assessment;Juillet;Global Forum,2011

3. Project management and international regulatory requirements and strategies for First-in-Human trials;Finkle,2010

4. First-in-Human regulatory submissions;Sommer,2010

5. The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety-M4S(R2) – Nonclinical Overview and Nonclinical Summaries of Module 2;International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2002

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch;Current Medical Research and Opinion;2021-07-08

2. Preclinical assessments of vaginal microbicide candidate safety and efficacy;Advanced Drug Delivery Reviews;2015-09

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