Analytical evaluation threshold

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Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
Dennis Jenke, Piet Christiaens and Ted Heise

PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 98-113; DOI: https://doi.org/10.5731/pdajpst.2024.012945
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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 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
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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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Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934

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Analytical evaluation threshold

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Parenteral Drug Association, Inc.