Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts-Reference-Cited by-同舟云学术

Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts

Published:2024-03-13 Issue:3 Volume:47 Page:611-619
ISSN:0918-6158
Container-title:Biological and Pharmaceutical Bulletin
language:en
Short-container-title:Biological & Pharmaceutical Bulletin

Author:

Watanabe Takashi¹,Ambe Kaori¹,Tohkin Masahiro¹

Affiliation:

1. Department of Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University

Publisher

Pharmaceutical Society of Japan

Link

https://www.jstage.jst.go.jp/article/bpb/47/3/47_b23-00846/_pdf

Reference18 articles.

1. 1) Pharmaceuticals and Medical Devices Agency. “Outline of post-marketing safety measures.”: ‹https://www.pmda.go.jp/english/safety/outline/0001.html›, accessed 01 November, 2023.

2. 2) Pharmaceuticals and Medical Devices Agency. “Standard workflow for consideration of safety measures such as revision of electronic drug product package inserts.”: ‹https://www.pmda.go.jp/files/000243072.pdf›, accessed 01 November, 2023.

3. 3) Pharmaceuticals and Medical Devices Agency. “Reference: standard workflow for consideration of safety measures.”: ‹https://www.pmda.go.jp/files/000243073.pdf›, accessed 01 November, 2023.

4. 4) Suzuki Y, Kishi T, Nakamura M, Yamada H. Evaluation of factors influencing addition of clinically significant adverse reactions section in drug package inserts. Jpn J. Drug Inform, 19, 17–23 (2017).

5. 5) CIOMS. “Practical aspects of signal detection in pharmacovigilance. Report of CIOMS working Group VIII.”: ‹https://cioms.ch/working_groups/working-group-viii/›, accessed 01 November, 2023.