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Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data

Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050

Article Information

vol. 69 no. 3 383-398
DOI 
https://doi.org/10.5731/pdajpst.2015.01050
PubMed 
26048745
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 4, 2015.
Copyright & Usage 
© PDA, Inc. 2015

Author Information

  1. Oliver Gordon1,
  2. Marcel Goverde3,
  3. James Pazdan4,
  4. Alexandra Staerk2 and
  5. David Roesti2,*
  1. 1Immunobiology Laboratory, Cancer Research UK London Research Institute, London UK;
  2. 2Microbiological Quality Control Unit, Novartis Pharma Stein AG, Stein, Switzerland;
  3. 3MGP Consulting GmbH, Binningen, Switzerland; and
  4. 4Pharma Development, Novartis Pharmaceuticals Corporation, Hanover, NJ, USA
  1. ↵*Corresponding Author: Novartis Pharma Stein AG, Schaffhauserstrasse, CH-4332 Stein, Switzerland. Telephone: +41 62 8686238; fax: +41628687180; e-mail: david.roesti{at}novartis.com
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Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk, David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: 10.5731/pdajpst.2015.01050
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