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Abstract

Traditionally, first in human clinical trials were mostly associated with a single ascending dose (SAD) design, which were subsequently followed by a multiple ascending dose (MAD) CT. Since then, integration of the non-clinical data available before FIH administration and the pharmacokinetic (PK), pharmacodynamic (PD) and human safety data emerging during a trial has evolved. Consequently, the increasing practice is to perform FIH trials and early phase CTs with integrated protocols that combine a number of different study parts, e.g. SAD, MAD, food effects, etc. The non-clinical testing and experimental approaches for FIH/early CTs are used to identify factors influencing the risks associated with an IMP. Special attention should be given to the estimation of the initial dose to be used in humans and to the subsequent dose escalations to a predefined maximum dose. In defining an appropriate development program for a new medicinal product, information on safety needs to be integrated from many sources and reviewed in an iterative process. This workshop is intended to discuss the transition from non-clinical to early clinical development by outlining factors influencing risk and how these should be mitigated in protocol design.

Biography

Email: david.jones@mhra.gsi.gov.uk