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PDA Journal of Pharmaceutical Science and Technology|December 27, 2024
Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and QuantitationDennis Jenke, Piet Christiaens, Ted HeiseJournal of Pharmaceutical and Biomedical Analysis|February 1, 2024
Identification and quantification of medical device extractables and leachables via non-target analysis (NTA); Analytical uncertaintyDennis Jenke, Piet Christiaens, Ted HeisePDA Journal of Pharmaceutical Science and Technology|November 17, 2020
The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor VariationDennis Jenke, Ted HeisePDA Journal of Pharmaceutical Science and Technology|November 16, 2021
Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?Dennis Jenke, Piet Christiaens, Philippe Verlinde, et al.PDA Journal of Pharmaceutical Science and Technology|June 19, 2019
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1-Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of OmissionPiet Christiaens, Jean-Marie Beusen, Philippe Verlinde, et al.PDA Journal of Pharmaceutical Science and Technology|July 17, 2019
Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2-Errors of Inexact Identification and Inaccurate QuantitationPiet Christiaens, Jean-Marie Beusen, Philippe Verlinde, et al.PDA Journal of Pharmaceutical Science and Technology|November 16, 2021
A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor VariationDennis Jenke, Piet Christiaens, Jean-Marie Beusen, et al.PDA Journal of Pharmaceutical Science and Technology|August 29, 2025
Use of the Retention Index to Secure Correct Identities in GC/MSPiet Christiaens, Dennis Jenke, Jan Baeten, et al.PDA Journal of Pharmaceutical Science and Technology|December 26, 2024
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 ConsiderationsDennis Jenke, Piet Christiaens, Philippe Verlinde, et al.PDA Journal of Pharmaceutical Science and Technology|August 20, 2025
Charting the Universe of Organic Extractables and Leachables Compounds with Confirmed identitiesDennis Jenke, Piet Christiaens, Adam Jenke, et al.Pageof 7