Framework for sensitization assessment of extractables and leachables in pharmaceuticals
P Parris, G Whelan, A Burild, J Whritenour… - Critical Reviews in …, 2022 - Taylor & Francis
During the toxicological assessment of extractables and leachables in drug products,
localized hazards such as irritation or sensitization may be identified. Typically, because of …
localized hazards such as irritation or sensitization may be identified. Typically, because of …
Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls)
M Masuda-Herrera, HT Rosen, A Burild… - Regulatory Toxicology …, 2023 - Elsevier
Health-based exposure limits (HBELs) are derived for leachables from polymeric
components that interact with the drug substance which exceed a safety concern threshold …
components that interact with the drug substance which exceed a safety concern threshold …
[HTML][HTML] An in silico workflow for assessing the sensitisation potential of extractables and leachables
ML Chilton, M Patel, AAF de Oliveira - Computational Toxicology, 2023 - Elsevier
As part of a wider toxicological risk assessment to ensure patient safety, extractables and
leachables (E&Ls) which are observed above the relevant qualification threshold need to be …
leachables (E&Ls) which are observed above the relevant qualification threshold need to be …
Evaluating the utility of the Threshold of Toxicological Concern (TTC) and its exclusions in the biocompatibility assessment of extractable chemical substances from …
Abstract The Threshold of Toxicological Concern (TTC) is a pragmatic approach used to
establish safe thresholds below which there can be no appreciable risk to human health …
establish safe thresholds below which there can be no appreciable risk to human health …
Occupational Toxicology in the Pharmaceutical Industry
Much of the activity in the pharmaceutical industry has its origins in the fine chemicals
industry of the late nineteenth century. At that time, advances in chemistry and medicine led …
industry of the late nineteenth century. At that time, advances in chemistry and medicine led …