Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation-Reference-Cited by-同舟云学术

Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation

Published:2017-04-27 Issue:4 Volume:16 Page:232-249
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Gamalo-Siebers Margaret¹^ORCID,Savic Jasmina²,Basu Cynthia³,Zhao Xin⁴,Gopalakrishnan Mathangi⁵,Gao Aijun⁶,Song Guochen⁷,Baygani Simin⁸,Thompson Laura⁹,Xia H. Amy¹⁰,Price Karen¹,Tiwari Ram¹¹,Carlin Bradley P.³

Affiliation:

1. Advanced Analytics; Eli Lilly & Co, Lilly Corporate Center; Indianapolis 46285 IN USA

2. JS Regulatory; Aachen Germany

3. Division of Biostatistics; University of Minnesota; Minneapolis 55455 MN USA

4. Biostatistics; Johnson & Johnson; South San Francisco 94080 CA USA

5. Research Assistant Professor, Center for Translational Medicine; University of Maryland; Baltimore 21201 MD USA

6. Biostatistics; Chiltern International Ltd.; King of Prussia 19406 PA USA

7. Biogen; Cambridge 02142 MA USA

8. Global Statistical Science; Eli Lilly & Co, Lilly Corporate Center; Indianapolis 46285 IN USA

9. Office of Surveillance and Biometrics, Center for Devices and Radiological Health; Food and Drug Administration; Silver Spring 20993 MD USA

10. Biostatistics; Amgen; Thousand Oaks 91320 CA USA

11. Office of Biostatistics, Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring 20993 MD USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pst.1807/fullpdf

Reference66 articles.

1. R. English Y. Lebovitz R. Griffin Institute of Medicine (US) Forum on Drug Discovery Development and Translation. Transforming clinical research in the United States. Challenges and opportunities: Workshop summary 2010

2. US Congress Best pharmaceuticals for children act http://www.fda.gov/opacom/laws/pharmkids/pharmkids.html 2002

3. US Congress Pediatric research equity act http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ155 2003

4. Identifying critical windows of exposure for children's health.

5. Differences Between Children and Adults: Implications for Risk Assessment at California EPA

Cited by 62 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Eliciting the Discount Parameter in a Power Prior Method on the Basis of the Type I Error Consideration;Statistics in Biopharmaceutical Research;2024-08-21

2. Developments in the Design, Conduct, and Reporting of Child Health Trials;Pediatrics;2024-06-04

3. Using Bayesian statistics in confirmatory clinical trials in the regulatory setting: a tutorial review;BMC Medical Research Methodology;2024-05-07

4. Implementation of Statistical Innovation in a Pharmaceutical Company;Statistics in Biopharmaceutical Research;2024-04-11

5. Design and Statistical Innovations in a Platform Trial for Amyotrophic Lateral Sclerosis;Annals of Neurology;2023-06-22