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Article CommentaryCommentary

An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET)

Mark Jordi and Ted Heise
PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 289-301; DOI: https://doi.org/10.5731/pdajpst.2020.012047
Mark Jordi
1Jordi Labs, Mansfield, MA; and
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  • For correspondence: mjordi@jordilabs.com
Ted Heise
2MED Institute Inc., West Lafayette, IN
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PDA Journal of Pharmaceutical Science and Technology: 75 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 3
May/June 2021
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An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET)
Mark Jordi, Ted Heise
PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 289-301; DOI: 10.5731/pdajpst.2020.012047
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  • Article
    • Abstract
    • Introduction: The Analytical Evaluation Threshold
    • AET Evaluation Using Multiple Orthogonal and Complementary Separation and Detection Methods
    • Answers to Some Potential Critiques
    • Practical Considerations When Applying a Multidetector AET Approach
    • Conclusion
    • Conflict of Interest Declaration
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Keywords

  • Extractables
  • Leachables
  • Analytical Evaluation Threshold
  • AET
  • Uncertainty Factor
  • Response factor variation
  • Multidetector approach

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An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET)
Mark Jordi, Ted Heise
PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 289-301; DOI: 10.5731/pdajpst.2020.012047

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