The Role of New Technologies in Defining a Manufacturing Process for PPARα Agonist LY518674-Reference-Cited by-同舟云学术

The Role of New Technologies in Defining a Manufacturing Process for PPARα Agonist LY518674

Published:2009-02-03 Issue:2 Volume:13 Page:131-143
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Argentine Mark D.¹,Braden Timothy M.¹,Czarnik Jeffrey¹,Conder Edward W.¹,Dunlap Steven E.¹,Fennell Jared W.¹,LaPack Mark A.¹,Rothhaar Roger R.¹,Scherer R. Brian¹,Schmid Christopher R.¹,Vicenzi Jeffrey T.¹,Wei Jeffrey G.¹,Werner John A.¹,Roginski Robert T.²

Affiliation:

1. Chemical Product Research and Development, Lilly Research Laboratories, A Division of Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, U.S.A.

2. Eigenvector Research, Inc., 3905 West Eaglerock Drive, Wenatchee, Washington 98801, U.S.A.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op8002486

Reference73 articles.

1. Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach.Final Report.Department of Health and Human Services, U.S. Food and Drug Administration:Washington, D.C., Fall (September) 2004; seehttp://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm.

2. SeeICH Guidelines Q8, Annex to Q8, and Q9; Available online at:http://www.ich.org/cache/compo/363-272-1.html.

3. Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.Department of Health and Human Services, U.S. Food and Drug Administration:Washington, D.C., September 2005. Seehttp://www.fda.gov/cder/guidance/6419fnl.pdf.

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