Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing-Reference-Cited by-同舟云学术

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Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing

Published:2010-04-19 Issue: Volume: Page:521-543
ISSN:
Container-title:Process Analytical Technology
language:
Short-container-title:

Author:

Bakeev Katherine A.,Menezes Jose C.

Publisher

John Wiley & Sons, Ltd

Reference55 articles.

1. US FDA 2004 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/Questionsand AnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374.pdf

2. US FDA 2004 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070305.pdf

3. http://www.ich.org/cache/compo/276-254- 1.html 2008

4. 2008 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf

5. PAT and green chemistry: the intersection of benign by design and quality by design;Cue;Pharm. Eng.,2009

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