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Research article

First published 1993-1

Individual Variation and the Acceptance of Average Bioequivalence

Laszlo Endrenyi, Miklos Schulz

Therapeutic Innovation & Regulatory Science

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Research article

First published 1996-11

Access to regulatory information in Malaysia – a preliminary study

Dzulkifli Abdul Razak

International Journal of Risk & Safety in Medicine

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Article commentary

First published 2023-7

The U.S. Food and Drug Administration,the mechanism of action,and other considerations for cell-based therapy candidates

Arnold I Caplan

Experimental Biology and Medicine

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Research article

First published 1994-03

Regulation of Oral Chemotherapeutic Products in the United States

C.L. Trummel

Journal of Dental Research

Open access

Research article

First published 2015-5

Expanded Access Programs

Mitchell Klopfenstein, Luann E. Van Campen, Timothy Garnett

Therapeutic Innovation & Regulatory Science

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Other

First published 1984-7

The Yale Algorithm Special Workshop—Clinical

Michael S. Kramer, Tom A. Hutchinson

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2012-11

The Minipig as Nonrodent Species in Toxicology—Where Are We Now?

Niels Christian Ganderup, Warren Harvey, Jens Thing Mortensen [...]

International Journal of Toxicology

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Review article

First published 2019

How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies?

Michaela Tutone, Federico Villa, Antonio Addis [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2000-1

Nonprescription Drug Regulation in the United States

Debra Bowen

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-7

The Over-the-Counter Scientific/Regulatory Paradigm

R. William Soller

Therapeutic Innovation & Regulatory Science

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