Clinical Pharmacology – Biomolecular
2019 PharmSci 360
Selection of FIH starting dose is critical for early clinical drug development. The approaches for determining FIH starting dose will be reviewed with scientific and strategic considerations. MABEL is one of the approaches to determine the starting dose for high-risk drugs. The IQ MABEL Working Group conducted an industry-wide survey on the use of MABEL based approach. The results from the survey will be shared with in-depth discussions and recommendations.