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Research article

First published 2025-12

Patent Portfolio Landscape in China’s Orange Book : Size Achievements and Persistent Quality Gaps Between Domestic Firms and Multinational Corporations

YAN LI, ZIYOU TENG

Biotechnology Law Report

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Other

First published 2001-4

Clinical Development of Therapeutic Medicines: A Biopharmaceutical versus Pharmaceutical Product Comparison

Janice M. Reichert

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-4

Phase I and II Trials: Designs and Strategies

Wayne A. Colburn

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-9

Analysis of Review Times for Recent 505(b)(2) Applications

Sharon Sakai, Joseph A. DiMasi, Kenneth A. Getz

Therapeutic Innovation & Regulatory Science

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Research article

First published 1993-10

Multinational Drug Development and Clinical Research: A Bird's Eye View of Principles and Practice

E. Philipp, T. R. Weihrauch

Therapeutic Innovation & Regulatory Science

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Research article

First published 2007-9

Using Data Mining to Predict Safety Actions from FDA Adverse Event Reporting System Data

Alan M. Hochberg, Stephanie J. Reisinger, Ronald K. Pearson [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-5

Pharmaceutical Pricing and Reimbursement in Japan

Akane Takayama, Mamoru Narukawa

Therapeutic Innovation & Regulatory Science

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Research article

First published 2009-03

Participation of Women in Clinical Trials for New Drugs Approved by the Food and Drug Administration in 2000–2002

Yongsheng Yang, Alan S. Carlin, Patrick J. Faustino [...]

Journal of Women's Health

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Research article

First published 2016-11

An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic

Petra Dörr, Alison Wadworth, Tina Wang [...]

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2019

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals

Cameron M. Kieffer, Alexis Reisin Miller, Benjamin Chacko [...]

Therapeutic Innovation & Regulatory Science

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