Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China-Reference-Cited by-同舟云学术

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Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

Published:2019-03 Issue:2 Volume:53 Page:227-232
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Wang Jun,Wang Gang^ORCID,Li Min,Han Jingjing,Zeng Xin,Pan Jianhong,Yang Jinbo^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479018778528.pdf

Reference30 articles.

1. FDA. Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring. Rockville, MD: FDA; 2013.

2. European Medicines Agency. Reflection paper on risk based quality management in clinical trials. 2011.

3. CFDA. Conducting self-inspection and verification of clinical trial data. 2015.

4. The State Council. The Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices. 2017.

5. CFDA. The guideline for biostatistics in clinical trials. 2016.

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