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Article CommentaryCommentary

Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies

Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 471-476; DOI: https://doi.org/10.5731/pdajpst.2015.01089
Dennis Jenke
Baxter Healthcare Corporation, 25212 West Illinois Route 120, Round Lake, IL 60073 USA
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PDA Journal of Pharmaceutical Science and Technology: 69 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
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Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 471-476; DOI: 10.5731/pdajpst.2015.01089

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Moving Forward towards Standardized Analytical Methods for Extractables and Leachables Profiling Studies
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 471-476; DOI: 10.5731/pdajpst.2015.01089
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  • Article
    • Abstract
    • Introduction
    • Problem Statement
    • The Challenge of Standardization
    • The Full Promise of Standardization: Profiling Enabled By a Knowledge Set
    • The Curse of Standardization: The Blind Application of Standardized Methods
    • The Question of Who Will Be the Hero
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More in this TOC Section

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  • Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
  • Parametric Release of Moist Heat Sterilized Products: History and Current State
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