Screening

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Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 329-338; DOI: https://doi.org/10.5731/pdajpst.2021.012671
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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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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, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 236-247; DOI: https://doi.org/10.5731/pdajpst.2021.012673

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