An Integrated Process Analytical Technology (PAT) Approach for Pharmaceutical Crystallization Process Understanding to Ensure Product Quality and Safety: FDA Scientist’s Perspective-Reference-Cited by-同舟云学术

An Integrated Process Analytical Technology (PAT) Approach for Pharmaceutical Crystallization Process Understanding to Ensure Product Quality and Safety: FDA Scientist’s Perspective

Published:2014-05-30 Issue:1 Volume:19 Page:89-101
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Wu Huiquan¹,Dong Zedong¹,Li Haitao¹,Khan Mansoor¹

Affiliation:

1. Division of Product Quality Research (DPQR), Office of Testing and Research, Office of Pharmaceutical Science, ‡Division of New Drug Quality Assessment I, Office of New Drug Quality Assessment, Office of Pharmaceutical Science, §Divsion of DMF Review, Office of Generic Drugs, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland, United States

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op500056a

Reference50 articles.

1. FDA. Advancing Regulatory Science at FDA: A Strategic Plan. August 2011.http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf(accessed on 12/30/ 2013) .

2. FDA. Guidance for Industry, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. 2004.http://www.fda.gov/downloads/drugs/guidances/ucm070305.pdf(accessed on 12/30/ 2013) .

3. FDA. Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances. 1987.http://www.fda.gov/downloads/Drugs/Guidances/UCM070632.pdf(accessed on 12/30/ 2013) .

4. FDA. Guidance for Industry, Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs. 2000.http://www.fda.gov/downloads/Drugs/Guidances/ucm072853.pdf(accessed on 12/30/ 2013) .

5. FDA. Guidance for Industry, ANDAs: Pharmaceutical Solid Polymorphism. 2007.http://www.fda.gov/downloads/Drugs/Guidances/UCM072866.pdf(accessed on 12/30/ 2013) .

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