IQ DILI Collaborates with Biorepository, DILI Experts, and US FDA to Publish in CPT
In collaboration with the IQ Drug Induced Liver Injury Initiative (IQ DILI), Biorepository and DILI experts from across academia, industry, and US FDA have collaborated to develop comprehensive guidelines addressing best practices for the collection of bio specimens that are consented for future use. Properly archived bio specimens will aid in the development and qualification of DILI biomarkers, as well as other biomarkers relevant to drug development. Their findings, featured in Clinical Pharmacology and Therapeutics, are based on extensive literature review and discussions between numerous drug safety & DILI subject matter experts to achieve consensus on general practices recommended for adequate collection and storage. This includes the logistics of the sample collection, but also consent documentation and the collection of clinical data that is temporally related to the sample.
Accces the article here (https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1571).