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PDA Journal of Pharmaceutical Science and Technology

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Review ArticleReview

PCMO L01—Setting Specifications for Biological Investigational Medicinal Products

Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 569-589; DOI: https://doi.org/10.5731/pdajpst.2015.01065
Stephan O. Krause
AstraZeneca Biologics, 633 Research Court, Frederick, MD 21703, USA; 301-398-2108;
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  • For correspondence: krauses@medimmune.com
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Article Information

vol. 69 no. 5 569-589
DOI 
https://doi.org/10.5731/pdajpst.2015.01065
PubMed 
26429107

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 1, 2015.

Copyright & Usage 
© PDA, Inc. 2015

Author Information

  1. Stephan O. Krause*
  1. AstraZeneca Biologics, 633 Research Court, Frederick, MD 21703, USA; 301-398-2108; krauses{at}medimmune.com
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PDA Journal of Pharmaceutical Science and Technology: 69 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 5
September/October 2015
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PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 569-589; DOI: 10.5731/pdajpst.2015.01065

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PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 569-589; DOI: 10.5731/pdajpst.2015.01065
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  • Article
    • Abstract
    • 1. Introduction and Scope
    • Abbreviations
    • 2. Control Strategy
    • 3. Setting and Justification of Specifications During Product Development
    • 4. Typical DS and DP Specification Revision and Justification Examples
    • 5. Case Study for Product Imp Specification Setting Process
    • 6. Discussion
    • Including Statistical Uncertainty
    • Conflict of Interest Declaration
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