Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan-Reference-Cited by-同舟云学术

Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan

Published:2022-01-07 Issue:3 Volume:21 Page:691-695
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Hirakawa Akihiro¹^ORCID,Sato Hiroyuki¹,Igeta Masataka²^ORCID,Fujikawa Kei³,Daimon Takashi²,Teramukai Satoshi³^ORCID

Affiliation:

1. Department of Clinical Biostatistics Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University Tokyo Japan

2. Department of Biostatistics Hyogo College of Medicine Nishinomiya Japan

3. Department of Biostatistics Graduate School of Medical Science, Kyoto Prefectural University of Medicine Kyoto Japan

Funder

Japan Agency for Medical Research and Development

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2192

Reference31 articles.

1. Pharmaceuticals and Medical Devices Agency.Director of the Pharmaceutical Evaluation Division Pharmaceutical Safety and Environmental Health Bureau Ministry of Health Labour and Welfare. Implementation of a conditional early approval system for pharmaceutical products.2017.https://www.pmda.go.jp/files/000227089.pdf. (Accessed 20 October 2021)

2. Pharmaceuticals and Medical Devices Agency.Cellular and tissue‐based products (regenerative medicines) reviews.https://www.pmda.go.jp/english/review-services/reviews/0001.html. (Accessed 20 October 2021)

3. Use of historical control data for assessing treatment effects in clinical trials

4. Bayesian Approaches to Randomized Trials

5. Idle thoughts of a ‘well-calibrated’ Bayesian in clinical drug development

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