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Research article

First published 2013-1

The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan

Yasuko Asahina, Ayumi Tanaka, Yoshiaki Uyama [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-7

Good Laboratory Practice Inspections in Japan Between Fiscal Years 2009-2011

Reiko Anahara

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-1

Valacyclovir-Induced Acute Kidney Injury in Japanese Patients Based on the PMDA Adverse Drug Reactions Reporting Database

Asuka Kitano, Hideyuki Motohashi, Akira Takayama [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-3

Evolving Global Regulatory Science Through the Voluntary Submission of Data

Elizabeth Gribble Walker, Martha Brumfield, Carolyn Compton [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-5

Transaction Cost Analysis of the New Drug Application Process

Shota Hamada, Akiko Shibata, Hisashi Urushihara [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2009-1

Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

Kazuhiko Mori, Sotoshi Toyoshima

Therapeutic Innovation & Regulatory Science

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Meeting report

First published 2025-6

2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: “Medical Device Safety Assessment: Pathology and Toxicology Perspective”

Flora Wegener, Antoine Alves, Uta Bussmeyer [...]

Toxicologic Pathology

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Research article

First published 2002-12

Human Factors: A Vital Component in Product Development and Launch

Cynthia Drake

Journal of Medical Marketing: Device,Diagnostic and Pharmaceutical Marketing

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Other

First published 2005-7

The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

Shunsuke Ono, Chisato Yoshioka, Orie Asaka [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-2

Preclinical biomarker qualification

John-Michael Sauer, Amy C Porter, for the Biomarker Programs,Predictive Safety Testing Consortium

Experimental Biology and Medicine

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