An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture-Reference-Cited by-同舟云学术

An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture

Published:2017-09-08 Issue: Volume: Page:9-24
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Container-title:Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
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Author:

Chatterjee Sharmista¹,Moore Christine M. V.²,Nasr Moheb M.³

Affiliation:

1. Office of New Drugs Quality Assessment; Food and Drug Administration; Silver Spring MD USA

2. Global CMC Policy; Merck, Inc.; Philadelphia PA USA

3. GlaxoSmithKline Pharmaceuticals; Brentford UK

Publisher

John Wiley & Sons, Inc.

Reference21 articles.

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4. ICH Q8 (R2), Pharmaceutical Development 2009 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf

5. FDA Guidance for Industry, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) Rockville 1997 1 27

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