PreS/MD: Predictor of Sensitization Hazard for Chemical Substances Released From Medical Devices.

ABSTRACT: In the United States, a pre-market regulatory submission for any medical device that comes into contact with either a patient or the clinical practitioner must include an adequate toxicity evaluation of chemical substances that can be released from the device during its intended use. These substances, also referred to as extractables and leachables, must be evaluated for their potential to induce sensitization/allergenicity, which traditionally has been done in animal assays such as the guinea pig maximization test (GPMT). However, advances in basic and applied science are continuously presenting opportunities to employ new approach methodologies, including computational methods which, when qualified, could replace animal testing methods to support regulatory submissions. Herein, we develo

SUBMITTER: Alves VM 

PROVIDER: S-EPMC9516038 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature