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First published 2008-3

Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations

Robert I. Roth

Therapeutic Innovation & Regulatory Science

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Research article

First published 2008-7

The Single Bioequivalence Study's Impact on the Dossier Broker

Richard L. DiCicco

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 1988-7

Cost-Benefit Analysis and Pricing Considerations in the Regulatory Arena

William H. Hubregs

Therapeutic Innovation & Regulatory Science

Free access

Review article

First published 2024-10

Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity,Drug Abuse Liability,and Pediatric Safety

Thulasi Ramani, Ronald L. Wange, T. Scott Manetz [...]

International Journal of Toxicology

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First published 2001-1

Preclinical Considerations for Regulatory Submissions

Paul Baldrick

Therapeutic Innovation & Regulatory Science

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Review article

First published 2013-5

Product Registration in Developing Countries

Yauba Saidu, Dario De Angelis, Silvia Aiolli [...]

Therapeutic Innovation & Regulatory Science

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First published 2009-11

The Changing Roles of Medical Communications Professionals: Evolution of the Core Curriculum

Alicia Alexander Cadogan, Stacey M. Fung

Therapeutic Innovation & Regulatory Science

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Research article

First published 2021-12

505(b) (2) - A smart pathway to differentiate from competitive,low margin environment of generics

Pooja Rathee, Swagat Tripathy, Sahil Khatter [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2011-2

The Pharmacogenetic Rescue of Side-Lined Anticancer Drugs to the Front-Line: Gefitinib as a Case Example

Alain Li-Wan-Po, Peter A Farndon, Susumu Kobayashi [...]

Annals of Pharmacotherapy

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First published 1998-7

A Study of Trends in Pharmaceutical Regulatory Approval Times for Nine Major Markets in the 1990s

Kate E. Thomas, Neil McAuslane, Christopher Parkinson [...]

Therapeutic Innovation & Regulatory Science

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