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Research article

First published 1997-1

Postapproval Changes in the United States—Is Life Getting Easier for Industry?

Helene Dumitriu

Therapeutic Innovation & Regulatory Science

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Review article

First published 2025-04

Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations

Gur Jai Pal Singh, S. Prasad Peri

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Other

First published 1999-7

Bulk Actives Post Approval Changes (BACPAC): A European Perspective

Chris Oldenhof

Therapeutic Innovation & Regulatory Science

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Other

First published 1999-7

Product Quality Research Initiative and Bulk Actives Post Approval Change

Daniel H. Gold, Stephen Byrn

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019

Estimating the Impact of Food and Drug Administration’s Unapproved Drug Initiative on Drug Prices and Sales

Dolly Sharma, Glen T. Schumock, Christopher D. Saffore [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2024-6

Optimizing the doses of cancer drugs after usual dose finding

Garth W Strohbehn, Walter M Stadler, Philip S Boonstra [...]

Clinical Trials

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Other

First published 2009-9

Constant Vigilance: The Role of Pharmaceutical Companies in Medicine Safety

Gretchen S. Dieck, Susan Betger, Daniel A. Kracov [...]

Therapeutic Innovation & Regulatory Science

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Review article

First published 2026-4

Regulatory Considerations for Medical Aerosol Products

Svetlana Lyapustina

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Research article

First published 1996-10

Statistical Assessment of Mean Differences between Two Dissolution Data Sets *

Yi Tsong, Thomas Hammerstrom, Pradeep Sathe [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2008-1

Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity

Yeong-Liang Lin

Therapeutic Innovation & Regulatory Science

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