Eudralex Volume 10 Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Eudralex Volume 10 Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

This guideline covers FIH/early CTs including those which generate initial knowledge in humans on tolerability, safety, PK and PD. These trials may also include collection of data on e.g. food or drug interactions, different age groups or gender, proof of concept and relative bioavailability of different formulations. These trials are often undertaken in healthy volunteers but can also include patients.