Potential of alkyl glycol ethers to cause endocrine disruption
An endocrine disruptor is defined as “an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations” (WHO/PCS, 2002). In recent years publications have appeared that mention individual glycol ethers or glycol ethers in general amongst those substances with […]
Probabilistic derivation of population thresholds for human skin sensitizer
Reynolds et al. has introduced the concept of a population threshold for human skin sensitizers – a chemical-specific exposure level at which no individual in a population will experience induction of contact allergy to a chemical. Therefore, a Bayesian multilevel (hierarchical) regression model was developed to estimate population thresholds under the conditions of a human-repeat-insult-patch-test. […]
Weight-of-evidence implementation for biocompatibility assessments
Biocompatibility Evaluation; Biological safety assessment. Regulatory guidances for biological safety describe biocompatibility evaluations of medical devices as a risk-based approach. However, they do not provide specific guidance on how to incorporating a holistic review of all the available data into a risk assessment. One of the major factors contributing to the difficulty of reviewing biocompatibility evaluations for market approval […]
Regulatory framework: Release of FDA Guidance for Use of International Standard ISO 10993-1
FDA has updated their guidance document on ISO 10993-1 to assist industry in preparing regulatory submissions. It incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in […]