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Research article

First published 1997-1

An Integrated Approach to the Preparation of Global CMC Dossiers

Peter C. Karlton, David Johnston

Therapeutic Innovation & Regulatory Science

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Other

First published 2022-3

Innovative medicine development

Valerie Pimpaneau, Emmanuelle Voisin

Technology and Health Care

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Research article

First published 2013-11

Statistics,Quality Review Issues,and Beyond for Generic Drug Applications in Taiwan

Lin-Chau Chang, Churn-Shiouh Gau

Therapeutic Innovation & Regulatory Science

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Research article

First published 2012-9

Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients

Daniel Capaldi, Kathy Ackley, Doug Brooks [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2007-7

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger [...]

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

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Other

First published 1998-4

Organization and Responsibilities of the Chemistry,Manufacturing,and Controls Function within Regulatory Affairs: A Survey of 17 Companies

Samuel T. Barnett, Roger W. Croswell, Anthony C. Cartwright [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1995-10

Quality Education: Regulatory Aspects in the Pharmaceutical Industry

G. Tabusso

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-5

Pre–Investigational New Drug Meetings With the FDA

Hong H. Vu, Anne R. Pariser

Therapeutic Innovation & Regulatory Science

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Research article

First published 1994-6

Regulatory Aspects of Modifications to Innovator Bronchodilator Metered Dose Inhalers and Development of Generic Substitutes

Wallace P. Adams, Guirag Poochikian, Alan S. Taylor [...]

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Other

First published 2002-7

Recommendations to the Food and Drug Administration: Metered Dose Inhaler Tests and Methods in the Chemistry,Manufacturing,and Controls Draft Guidances for Metered Dose Inhalers and Dry Powder Inhalers

Lee M. Nagao

Therapeutic Innovation & Regulatory Science

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