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Articles (12)

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1-10 of 12 results for NDA preparation

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Select article: Six Enduring Principles for Preparing NDAS

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Other

First published 2000-7

Six Enduring Principles for Preparing NDAS

Michael J. Umen

Therapeutic Innovation & Regulatory Science

Select article: Clinical Evaluation and NDA Preparation

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Research article

First published 1982-1

Clinical Evaluation and NDA Preparation

Paul M. Worrall

Therapeutic Innovation & Regulatory Science

Select article: Data Processing Coordination in NDA Preparation

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Research article

First published 1976-10

Data Processing Coordination in NDA Preparation

Gary Bazalo

Therapeutic Innovation & Regulatory Science

Select article: Demonstrating the Effectiveness of the Quality Systems for An FDA Pre-NDA Approval Inspection

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Research article

First published 1994-10

Demonstrating the Effectiveness of the Quality Systems for An FDA Pre-NDA Approval Inspection

David Johnston

Therapeutic Innovation & Regulatory Science

Select article: The Value of Candas in Drug Development

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Research article

First published 1996-1

The Value of Candas in Drug Development

Stephanie Kirk

Therapeutic Innovation & Regulatory Science

Select article: NDA Day Strategy and Success for ICI Pharmaceuticals Group's Diprivan® (PROPOFOL)

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Research article

First published 1992-7

NDA Day Strategy and Success for ICI Pharmaceuticals Group's Diprivan® (PROPOFOL)

Gustavo Acosta, Nanette E. Holston

Therapeutic Innovation & Regulatory Science

Select article: What is the Future of the Canda at FDA?

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Research article

First published 1994-4

What is the Future of the Canda at FDA?

Robert A. Bell

Therapeutic Innovation & Regulatory Science

Select article: The “N” in Pain is Silent: One Company's Approach to FDA Prenda Approval Inspections

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First published 1998-7

The “N” in Pain is Silent: One Company's Approach to FDA Prenda Approval Inspections

Martin D. Hynes, Richard M. Justice, Jole O. Rodriguez [...]

Therapeutic Innovation & Regulatory Science

Select article: Thermotropic copolyesters from methylhydroquinone,4,4'-dipbenyldicarboxylic acid and 2,6-naphthalenedicarboxylic acid

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Research article

First published 1995-06

Thermotropic copolyesters from methylhydroquinone,4,4'-dipbenyldicarboxylic acid and 2,6-naphthalenedicarboxylic acid

Toshihide Inoue, Toru Yamanaka, Norikazu Tabata [...]

High Performance Polymers

Select article: More Similarities than Differences

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Research article

First published 1988-10

More Similarities than Differences

Marion J. Finkel

Therapeutic Innovation & Regulatory Science

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