Literature DB >> 27222073

The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan.

Chieko Ishiguro1, Yoshinori Takeuchi1, Yoshiaki Uyama1, Tomiko Tawaragi1.   

Abstract

Keywords:  pharmacoepidemiology; post-marketing drug safety; regulatory science

Mesh：

Substances：

Year:  2016        PMID： 27222073     DOI： 10.1002/pds.4032

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN： 1053-8569            Impact factor:   2.890


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  7 in total

1.  Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies.

Authors:  Yumi Wakabayashi; Masamitsu Eitoku; Narufumi Suganuma
Journal:  BMC Med Inform Decis Mak       Date:  2021-05-22       Impact factor: 2.796

Review 2.  Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan.

Authors:  Kinue Nishioka; Tomomi Makimura; Akihiro Ishiguro; Takahiro Nonaka; Mitsune Yamaguchi; Yoshiaki Uyama
Journal:  Clin Pharmacol Ther       Date:  2021-09-18       Impact factor: 6.903

3.  Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence.

Authors:  Mary Wiktorowicz; Kathy Moscou; Joel Lexchin
Journal:  Global Health       Date:  2018-08-22       Impact factor: 4.185

4.  Establishment of the MID-NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Authors:  Mitsune Yamaguchi; Satomi Inomata; Sayoko Harada; Yu Matsuzaki; Maiko Kawaguchi; Mayuko Ujibe; Mari Kishiba; Yoshiaki Fujimura; Michio Kimura; Koichiro Murata; Naoki Nakashima; Masaharu Nakayama; Kazuhiko Ohe; Takao Orii; Eizaburo Sueoka; Takahiro Suzuki; Hideto Yokoi; Fumitaka Takahashi; Yoshiaki Uyama
Journal:  Pharmacoepidemiol Drug Saf       Date:  2019-08-29       Impact factor: 2.890

5.  Characteristics of hospital differences in missing of clinical laboratory test results in a multi-hospital observational database contributing to MID-NET® in Japan.

Authors:  Maki Komamine; Yoshiaki Fujimura; Yasuharu Nitta; Masatomo Omiya; Masaaki Doi; Tosiya Sato
Journal:  BMC Med Inform Decis Mak       Date:  2021-06-06       Impact factor: 2.796

Review 6.  Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval.

Authors:  Shunsuke Matsushita; Keisuke Tachibana; Tetsuya Kusakabe; Ryuichi Hirayama; Yasuo Tsutsumi; Masuo Kondoh
Journal:  Clin Transl Sci       Date:  2021-04-03       Impact factor: 4.689

7.  Validation of novel identification algorithms for major adverse cardiovascular events in a Japanese claims database.

Authors:  Daisuke Shima; Yoichi Ii; Shingo Higa; Takahide Kohro; Satoshi Hoshide; Ken Kono; Shigeru Fujimoto; Satoshi Niijima; Naoko Tomitani; Kazuomi Kario
Journal:  J Clin Hypertens (Greenwich)       Date:  2020-12-26       Impact factor: 3.738
  7 in total

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