Article Information
PubMed
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History
- Published online January 26, 2011.
Copyright & Usage
©PDA, Inc. 2011
Author Information
- 1Office of Compliance, Division of Manufacturing and Product Quality, CDER, FDA and
- 2Office of Pharmaceutical Science, New Drug Microbiology Staff, CDER, FDA
- * Corresponding author: Anastasia G. Lolas, Biotechnology Manufacturing Team, Division of Manufacturing and Product Quality, Office of Compliance, CDER, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Bldg 51, Room 4216, Silver Spring, MD 20993-0002. Phone: 301-796-1566. E-mail: anastasia.lolas{at}fda.hhs.gov
Cited By...
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- Article
- Abstract
- Introduction
- Microbial Growth Studies
- Water Activity as a Tool for Evaluating the Microbial Growth Potential of Nonsterile Pharmaceutical Dosage Forms
- Sterile Pharmaceutical Dosage Forms
- Microbial Growth Potential and QbD—Examples and Case Studies
- Summary
- Disclaimer
- Conflict of Interest Declaration
- References
- References
- Info & Metrics
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