Research ArticleTechnology/Application
Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
Anastasia G. Lolas and John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology January 2011, 65 (1) 63-70;
Anastasia G. Lolas

References
- 1.↵
AAPS Workshop on Pharmaceutical Quality Assessment—A Science and Risk-Based CMC Approach in the 21st Century; North Bethesda, MD, October 5–7, 2005.
- 2.↵
Federal Register, Vol. 70, No. 134; 2005. U.S. Department of Health and Human Services, Food and Drug Administration. Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program.
- 3.↵
Federal Register, Vol. 73, No. 128; 2008. U.S. Department of Health and Human Services, Food and Drug Administration. Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program.
- 4.↵
U.S. Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonization, Guidance for Industry: Q8 Pharmaceutical Development (2006) and Q8(R1) Pharmaceutical Development Revision 1 (2007). Rockville, MD.
- 5.↵
- Metcalfe J. W.
- 6.↵
- Friedel R. R.,
- Cundell A. M.
- 7.↵
- Fontana A. J.
- 8.↵
United States Pharmacopeia—National Formulary (USP 29-NF 24) 2006. 〈1112〉 Application of Water Activity Determination to Nonsterile Pharmaceutical Products. Washington, D.C., p. 3802–3803.
- 9.↵
- Snider B.,
- Liang P.,
- Pearson N.
- 10.↵
U.S. Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonization, Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Rockville, MD, 2000.
- 11.↵
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Rockville, MD, 2010.
- 12.↵
- Noecker R.
- 13.↵
- Graf P.,
- Hallen H.,
- Juto J.-E.
- 14.↵
- Perrenoud D.,
- Bircher A.,
- Hunziker T.,
- Suter H.,
- Bruckner-Tuderman L.,
- Stäger J.,
- Thürlimann W.,
- Schmid P.,
- Suard A.,
- Hunziker N.
- 15.↵
- 16.↵
- McNeil M. M.,
- Lasker B. A.,
- Lott T. J.,
- Jarvis W. R.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 1
January/February 2011
Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
Anastasia G. Lolas, John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 63-70;
Jump to section
- 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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