Article Information
PubMed
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History
- Published online May 1, 2007.
Copyright & Usage
Copyright © Parenteral Drug Association. All rights reserved.
Author Information
- Steve Buchholz, PH.D.1,
- Victor J. Gangi2,*,
- Anne Johnson3,
- Jacqueline Little, PH.D.3,
- Steven Mendivil4,
- Carolyn Trott5,
- Keith Webber, PH.D.3 and
- Mark Weinstein, PH.D.3
- 1Pfizer, Inc.,
- 2Wyeth Biopharma,
- 3US FDA,
- 4Amgen Inc.,
- 5Genzyme Corp., Product Quality Research Institute Work Group
- *Corresponding Author: Victor J. Gangi, Director CMC, Regulatory Affairs, Wyeth Biopharma, 1 Burtt Road, Andover, MA 01810. Phone 978-247-4756, Fax: 978-684-4856, E-mail: gangiv{at}wyeth.com