Dennis Jenke
Overview
Explore the profile of Dennis Jenke including associated specialties, affiliations and a list of published articles.
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Articles
53
Citations
86
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Recent Articles
1.
Jenke D, Christiaens P, Heise T
PDA J Pharm Sci Technol
. 2024 Dec;
79(1):98-113.
PMID: 39730201
Substances leached from a medical device during its clinical use are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables...
2.
Jenke D, Christiaens P, Verlinde P, Baeten J, Beusen J
PDA J Pharm Sci Technol
. 2024 Dec;
78(6):625-642.
PMID: 39725482
Leachables in drug products and from medical devices can adversely affect patient health and thus must be identified and quantified. Accurate and protective quantitation in target analysis for leachables (and...
3.
Jenke D, Christiaens P, Heise T
J Pharm Biomed Anal
. 2024 Feb;
241:115985.
PMID: 38301578
Leachables are substances that are leached from a medical device during its clinical use and are important due to the patient health-related effects they may have. Thus, medical devices are...
4.
Jenke D
PDA J Pharm Sci Technol
. 2023 Nov;
78(3):358-366.
PMID: 37973191
Leachables are quantified and identified to enable their quantitative toxicological safety risk assessment (qTSRA). The leachable's reported concentration and identity must meet certain quality expectations to be suitable for qTSRA....
5.
Jenke D
PDA J Pharm Sci Technol
. 2023 Mar;
77(4):329-338.
PMID: 37001885
Drug products and medical devices can contain leachable impurities that could adversely affect patient health during their clinical use. To establish patient exposure to leachables, drug products and packaging, manufacturing...
6.
Jenke D, Christiaens P, Verlinde P, Baeten J, Beusen J
PDA J Pharm Sci Technol
. 2021 Nov;
76(3):236-247.
PMID: 34782445
Leachables can potentially and adversely affect patient safety. Thus, drug products and medical devices are chromatographically screened for organic leachables (and extractables), establishing these compounds' identity and quantity. Accurate quantitation...
7.
Jenke D, Christiaens P, Beusen J, Verlinde P, Baeten J
PDA J Pharm Sci Technol
. 2021 Nov;
76(3):178-199.
PMID: 34782443
The analytical evaluation threshold (AET) establishes which chromatographic peaks, produced during organic extractables/leachables (E&L) screening, require toxicological safety risk assessment because the peaks are associated with compounds of potentially unacceptable...
8.
A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
Jenke D
PDA J Pharm Sci Technol
. 2021 May;
75(6):506-535.
PMID: 33990423
During storage and distribution of a packaged drug product, chemical substances present in or on the packaging may leach into the drug product, potentially adversely affecting the drug product's key...
9.
Jenke D, Heise T
PDA J Pharm Sci Technol
. 2020 Nov;
75(3):273-288.
PMID: 33199516
A drug product is chromatographically screened for organic leachables, derived from the product's packaging system, as leachables might adversely impact the health of a patient to whom the drug product...
10.
Jenke D
PDA J Pharm Sci Technol
. 2020 Apr;
74(3):348-358.
PMID: 32295860
It is generally acknowledged that quantitation in extractables and leachables (E&L) can be variably reproducible and accurate, depending on the quantitation approach taken. This is especially true for "simple" quantitation,...