Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications-Reference-Cited by-同舟云学术

Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications

Published:2019-04-12 Issue:4 Volume:12 Page:334-342
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Chiodin Davy¹,Cox Erica M.²,Edmund Anita V.³,Kratz Erica²,Lockwood Sarah H.²

Affiliation:

1. Acerta Pharma South San Francisco CA USA

2. Denali Therapeutics Inc. South San Francisco CA USA

3. Impact Clinical, LLC Escondido CA USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12635

Reference33 articles.

1. Fifty Years Later: The Significance of the Nuremberg Code

2. International Council on Harmonisation (ICH).Harmonised Guideline. Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Current Step 4 version. (2016). Accessed January 25 2019.

3. International Council on Harmonisation (ICH).Guidelines website. Accessed February 18 2019.

4. US Food and Drug Administration (FDA).Guidance search website. Accessed February 18 2019.

5. European Medicines Agency (EMA).Scientific guidelines. Accessed February 18 2019.

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