
In Print:
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D. Jenke, P. Christiaens, J.M. Beusen, P. Verlinde, and J. Baeten. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part I; Introduction to Errors in Chromatographic Screening for Organic Extractables & Leachables and Discussion of the Error of Omission. PDA J Pharm Sci Technol; 74(1): 90-107 (2020).
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D. Jenke, P. Christiaens, J.M. Beusen, P. Verlinde, and J. Baeten. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: The Errors of Inexact Identification and Inaccurate Quantitation. PDA J Pharm Sci Technol. 74(1): 108-133 (2020).
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D. Jenke. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3: Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices. PDA J Pharm Sci Technol. 74(1): 134-146 (2020).
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D. Jenke. Identification and quantitation classifications for extractables and leachables. PDA J Pharm Sci Technol. 74(2), 275-285 (2020).
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D. Jenke. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review. PDA Journal of Pharm Sci Technol. 74(3): 324-347 (2020).
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D. Jenke. Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables. PDA Journal of Pharm Sci Technol. 74(3): 348-358 (2020).
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D. Jenke, T. Heise. The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the AET Adjusted for Response Factor Variation. PDA Journal of Pharm Sci Technol. pdajpst.2020.012013; DOI: https://doi.org/10.5731/pdajpst.2020.012013.