Regulatory Science of Medical Products

Regulatory Science of Medical Products

Published by Society for Regulatory Science of Medical Products

304 registered articles
(updated on May 02, 2025)

Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113

JOURNAL PEER REVIEWED RESTRICTED ACCESS

2025 Volume 15 Issue 1

[title in Japanese] [in Japanese]
Overview of ICH Q13 Guideline for Continuous Manufacturing of Drug Substances and Drug Products Kosuke ITO
A New Approach to Support Continuing Medical Education for Healthcare Professionals : Independent Medical Education Grants (IME Grants) Akihiro KAMINA, Yukio MORITSUGU, Yukiko YANAGIDA, Tatsuya UMEDA, Tetsuya YUZURIHA, Ayumi NOMOTO
Current Status of Development and Approval Details for Approved Pediatric Drugs, and Future Consideration for Pediatric Drug Development in Japan Yuki NAKAYAMA, Emiko YAMASAKI, Taku ONISHI, Hiroko SANO, Yukiko WATABE, Mariko KOZAI

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Most viewed articles (March 2025)

1

Comparison of the Japanese Pharmacopoeia, United States Pharmacopeia, and European Pharmacopoeia : Consideration on Similarities and Differences on Constitution, General Notices, and Control of Impurities

Released on J-STAGE: May 31, 2018 | Volume 8 Issue 2 Pages 55-68

Maki MATSUHAMA, Chie MIZUMARU, Seiko MIYAZAKI

Views: 540
2

A Study on the Starting Dose in the First-in-human Study for New Drugs Approved in Japan

Released on J-STAGE: May 31, 2022 | Volume 12 Issue 2 Pages 143-152

Haruka YAGI, Mamoru NARUKAWA

Views: 152
3

Current Status and Trends of In Vivo Diagnostics

Released on J-STAGE: January 31, 2019 | Volume 9 Issue 1 Pages 5-15

Yoshinori TSUKUMO, Takayoshi SUZUKI, Mikihiko NAITO

Views: 118
4

Basic Principles of Biological Safety Evaluation Required for Application for Approval to Japanese Market Medical Devices and Trends of Related ISO Standards

Released on J-STAGE: May 31, 2020 | Volume 10 Issue 2 Pages 47-54

Keisuke SAKAGUCHI

Views: 115
5

Basic Concepts and Clinical Application of Regenerative Medicine for Hair Loss Using Human Cells and Tissues

Released on J-STAGE: February 05, 2016 | Volume 6 Issue 1 Pages 91-99

Yosuke NAKAZAWA, Takashi SATOH, Seiji SATO, Tsutomu SOMA, Ritsuro IDETA, Yoshinori ISHII, Shiro NIIYAMA, Ryoji TSUBOI, Jiro KISHIMOTO

Views: 113

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