Uncertainty factor

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Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski

PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 4-27; DOI: https://doi.org/10.5731/pdajpst.2024.012964
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Correlating GC/MS Relative Response Factors to Analyte’s Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 625-642; DOI: https://doi.org/10.5731/pdajpst.2023.012884
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The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
Dennis Jenke and Ted Heise

PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 273-288; DOI: https://doi.org/10.5731/pdajpst.2020.012013
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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 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
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Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: https://doi.org/10.5731/pdajpst.2019.010520
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Quantitative Microbial Risk Assessment of Pharmaceutical Products
Mostafa Essam Eissa

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: https://doi.org/10.5731/pdajpst.2016.007047

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Uncertainty factor

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Parenteral Drug Association, Inc.