Current Practices of Process Validation for Drug Substances and Intermediates-Reference-Cited by-同舟云学术

Current Practices of Process Validation for Drug Substances and Intermediates

Published:2010-12-21 Issue:1 Volume:15 Page:162-172
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Anderson Neal G.¹,Burdick David C.¹,Reeve Maxwell M.¹

Affiliation:

1. Anderson’s Process Solutions, 7400 Griffin Lane, Jacksonville, Oregon 97530, United States, Creative Innovation Partners, 1971 Western Avenue, Albany, New York 12203, United States, and Rib-X Pharmaceuticals Inc., 300 George Street, New Haven, Connecticut 06511, United States

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op1002825

Reference74 articles.

1. GREEN CHEMISTRY PROGRESS REPORT

2. NEXT-GENERATION RISK ASSESSMENT

3. Repic, O.Principles of Process Research and Chemical Development in the Pharmaceutical Industry;Wiley:New York, 1998; pp179−94.

4. Dimethyltitanocene: From Millimole to Kilomole

5. Guideline on General Principles of Validation; 1987, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm(accessed 10/19/10).

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