The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations-Reference-Cited by-同舟云学术

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The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

Published:2015-07-03 Issue:3 Volume:7 Page:174-190
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Wittes Janet,Crowe Brenda,Chuang-Stein Christy,Guettner Achim,Hall David,Jiang Qi,Odenheimer Daniel,Xia H. Amy,Kramer Judith

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

http://www.tandfonline.com/doi/pdf/10.1080/19466315.2015.1043395

Reference23 articles.

1. Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

2. Accounting for Multiplicities in Assessing Drug Safety: A Three-Level Hierarchical Mixture Model

3. Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies

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5. Aggregate Safety Assessment Planning for the Drug Development Life-Cycle;Therapeutic Innovation & Regulatory Science;2021-03-23

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