Phase I Studies and First-In-Human Trials-Reference-Cited by-同舟云学术

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Phase I Studies and First-In-Human Trials

Published:2016 Issue: Volume: Page:85-95
ISSN:
Container-title:Clinical Pharmacology: Current Topics and Case Studies
language:
Short-container-title:

Author:

Derhaschnig Ulla,Jilma Bernd

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-27347-1_7

Reference22 articles.

1. European Medicines Agency (1998) ICH topic E8 general considerations for clinical trials. Note for guidance on general considerations for clinical trials. EMEA/CPMP/ICH/291/95

2. Duff G (2006) Expert Scientific Group on phase one clinical trials final report. Stationery Office, Norwich

3. European Medicines Agency (1998) ICH guideline S6 pre-clinical safety evaluation of biotechnology-derived products. EMEA/CPMP/ICH/302/95

4. European Medicines Agency (2000) ICH guideline M3 (R1) non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. EMEA/CPMP/ICH/286/95

5. European Medicines Agency, Committee for Medicinal Products for Human Use (2007) Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. EMEA/CHMP/SWP/28367/07

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