- First-in-human: what dose to choose to elicit the desired effect (efficacy), without causing harm (safety)?
- Translation of the preclinical information to human clinical trials is challenging.
- Scaling of the ‘No Adverse Effect Level’ dose based on body-weight or BSA has proven its limits, especially for biologics.
Presented at ACoP 11 Virtual Conference, Nov. 9-13, 2020
By Géraldine Ayral, Pauline Traynard, Monika Twarogowska