Intra-target Micro-dosing 1st In-human Clinical Trials to Speed Up Drug Discovery – Manufacturing And Regulatory Aspects

Synopsis

Drug development is a lengthy, complex and expensive activity, which leads to a large temporal discrepancy between scientific discoveries and their use in clinics. Intra-target Micro-dosing trials attempt to shorten this delay by delivering a safe, low, non-therapeutic dose directly at the disease site to extract important pharmacodynamic data to assess API efficiency from the target patient cohort. The manufacturing and regulatory context differs from classical clinical trial, and the platform set up by the Translational Healthcare Technologies group of the University of Edinburgh answers these specific needs.