Adaptability of AI for safety evaluation in regulatory science: A case study of drug-induced liver injury.

ABSTRACT: Artificial intelligence (AI) has played a crucial role in advancing biomedical sciences but has yet to have the impact it merits in regulatory science. As the field advances, in silico and in vitro approaches have been evaluated as alternatives to animal studies, in a drive to identify and mitigate safety concerns earlier in the drug development process. Although many AI tools are available, their acceptance in regulatory decision-making for drug efficacy and safety evaluation is still a challenge. It is a common perception that an AI model improves with more data, but does reality reflect this perception in drug safety assessments? Importantly, a model aiming at regulatory application needs to take a broad range of model characteristics into consideration. Among them is adap

SUBMITTER: Connor S 

PROVIDER: S-EPMC9679417 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature