Výsledky vyhledávání - "Piet Christiaens"

A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation

Autor: Jan Baeten, Philippe Verlinde, Piet Christiaens, Dennis Jenke, Jean-Marie Beusen

Publikováno v: PDA Journal of Pharmaceutical Science and Technology. 76:178-199

The analytical evaluation threshold (AET) establishes which chromatographic peaks, produced during organic extractables/leachables (EL) screening, require toxicological safety risk assessment because the peaks are associated with compounds of potenti

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::193d23f87cc051fe8e26abad9734e74e
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?

Autor: Jan Baeten, Piet Christiaens, Philippe Verlinde, Jean-Marie Beusen, Dennis Jenke

Publikováno v: PDA journal of pharmaceutical science and technology. 76(3)

Leachables in drug products or from medical devices could potentially and adversely affect patient safety. Thus, drug products and medical devices are chromatographically screened for organic leachables (and extractables), establishing these compound

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b03b1ff8ad8d9fc15b91c7cafd66d9c0
https://pubmed.ncbi.nlm.nih.gov/34782445

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Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2-Errors of Inexact Identification and Inaccurate Quantitation

Autor: Philippe Verlinde, Piet Christiaens, Jan Baeten, Jean-Marie Beusen, Dennis Jenke

Publikováno v: PDA journal of pharmaceutical science and technology. 74(1)

Patients can be exposed to leachables derived from pharmaceutical manufacturing systems, packages and /or medical devices during a clinical therapy. These leachables can adversely decrease the therapy′s effectiveness and/or adversely impact patient

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::45564c29fef17830244fa012c6045834
https://pubmed.ncbi.nlm.nih.gov/31308065

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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 Omission

Autor: Jean-Marie Beusen, Dennis Jenke, Philippe Verlinde, Jan Baeten, Piet Christiaens

Publikováno v: PDA journal of pharmaceutical science and technology. 74(1)

Substances leached from materials used in pharmaceutical manufacturing systems, packages, and/or medical devices can be administered to a patient as part of a clinical therapy. These leachables can have an undesirable effect on the effectiveness of t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48433b85644f3bb32e8e77d148aa05fb
https://pubmed.ncbi.nlm.nih.gov/31209164

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Kinetic Investigation of the Reactions of Mg(1S), Ca(1S), and Sr(1S) Atoms with NO2 over the Temperature Ranges 303−836, 303−916, and 303−986 K, Respectively

Autor: Joëlle Helaers, Piet Christiaens, Jan Remeysen, Chris Vinckier

Publikováno v: The Journal of Physical Chemistry A. 103:11321-11327

The kinetics of the second-order reactions Mg(1S) + NO2(X2A1) MgO + NO, Ca(1S) + NO2(X2A1) CaO + NO, and Sr(1S) + NO2(X2A1) SrO + NO have been investigated in a fast-flow reactor in the temperature ranges of, respectively, 303−836, 303−916, and 3

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::66e54c97600c46126d9c1e55bb7e79b4
https://doi.org/10.1021/jp9920500

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