Case Studies in the Applicability of Drug Substance Design Spaces Developed on the Laboratory Scale to Commercial Manufacturing-Reference-Cited by-同舟云学术

Case Studies in the Applicability of Drug Substance Design Spaces Developed on the Laboratory Scale to Commercial Manufacturing

Author:

Thomson Nicholas M.¹,Seibert Kevin D.²,Tummala Srinivas³,Bordawekar Shailendra⁴,Kiesman William F.⁵,Irdam Erwin A.⁵,Phenix Brian⁶,Kumke Daniel⁷

Affiliation:

1. Chemical Research and Development, Pfizer Inc., Eastern Point Road, Groton, Connecticut 06340, United States

2. Small Molecule Design and Development, Eli Lilly and Co., Lilly Technology Center, Indianapolis, Indiana 46285, United States

3. Chemical Development, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, New Jersey 08903, United States

4. Process Research and Development, AbbVie, 1 North Waukegan Road, North Chicago, Illinois 60064, United States

5. Chemical Process Research and Development, Biogen Idec, 14 Cambridge Center, Cambridge, Massachusetts 02142, United States

6. Chemical Development, Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, Massachusetts 02210, United States

7. Chemical Process Development and Commercialization, Merck, 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

Reference11 articles.

1. Questions and Answers on Design Space Verification.http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/11/WC500153784.pdf.

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