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Research ArticleResearch

A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation

Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde and Jan Baeten
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 178-199; DOI: https://doi.org/10.5731/pdajpst.2021.012692
Dennis Jenke
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; Telephone: ++32(0)16400484; and
2Triad Scientific Solutions, 181 Peregrine Lane Hawthorn Woods, IL 60047
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  • For correspondence: dennisjenke@triadscientificsolutions.com
Piet Christiaens
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; Telephone: ++32(0)16400484; and
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Jean-Marie Beusen
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; Telephone: ++32(0)16400484; and
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Philippe Verlinde
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; Telephone: ++32(0)16400484; and
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Jan Baeten
1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; Telephone: ++32(0)16400484; and
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Article Information

vol. 76 no. 3 178-199
DOI 
https://doi.org/10.5731/pdajpst.2021.012692
PubMed 
34782443

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 1, 2022.

Article Versions

  • previous version (November 15, 2021 - 03:48).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2022

Author Information

  1. Dennis Jenke1,2,*,
  2. Piet Christiaens1,
  3. Jean-Marie Beusen1,
  4. Philippe Verlinde1 and
  5. Jan Baeten1
  1. 1Nelson Labs, Romeinsestraat 12, 3001 Heverlee, Belgium; Telephone: ++32(0)16400484; and
  2. 2Triad Scientific Solutions, 181 Peregrine Lane Hawthorn Woods, IL 60047
  1. ↵*Corresponding Author: Triad Scientific Solutions, LLC; E-mail: dennisjenke{at}triadscientificsolutions.com
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PDA Journal of Pharmaceutical Science and Technology: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
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A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation
Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 178-199; DOI: 10.5731/pdajpst.2021.012692

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A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation
Dennis Jenke, Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 178-199; DOI: 10.5731/pdajpst.2021.012692
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  • Article
    • Abstract
    • Introduction
    • The Concept of Coverage
    • Illustrating the Concept of “Optimizing to the Point of Diminishing Returns
    • The Nelson Response Factor Database
    • Application of the RRF Data in Setting the UF Values
    • Conclusion
    • Conflict of Interest Declaration
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  • Challenges Associated with Biological Safety Assessments for Drug-Device Combination Products
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Keywords

  • Organic extractables and leachables
  • Analytical Evaluation Threshold
  • Uncertainty factor adjustment
  • AET
  • Screening

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