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The available mechanistic information provided support for the biological plausibility of the phenotypic effects observed in exposed animals, as well as the activation of relevant molecular and cellular pathways across human and animal models

doi:10.1002/ptr.1953

The aim of this publication is to serve as a tutorial for conducting FIH trials for both small molecule and biological drug candidates with topics covering regulatory requirements, preclinical safety testing, study design considerations, safety monitoring, biomarker assessment, and global considerations

Topical numbing creams are usually applied before the procedure to minimize pain