Biometrical issues in the analysis of adverse events within the benefit assessment of drugs-Reference-Cited by-同舟云学术

Biometrical issues in the analysis of adverse events within the benefit assessment of drugs

Published:2016-02-29 Issue:4 Volume:15 Page:292-296
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Bender Ralf¹²,Beckmann Lars¹,Lange Stefan¹

Affiliation:

1. Institute for Quality and Efficiency in Health Care (IQWiG) Cologne Germany

2. Faculty of Medicine University of Cologne Cologne Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.1740

Reference27 articles.

1. An Overview of the Regulatory Approval Process in Drug Development

2. Safety Analysis in Controlled Clinical Trials

3. IQWiG. General Methods Version 4.2 of 22 April 2015 IQWiG Cologne 2015 Available at:https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204‐2.pdf(accessed 23 October 2015).

4. Statistical Evaluation of Drug Safety Data

5. Analysis of safety data in clinical trials using a recurrent event approach

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