From Preclinical to Clinical Drug Product Development:​ A Path for Smooth Transition

From Preclinical to Clinical Drug Product Development:​ A Path for Smooth Transition

Authors: Suarez-Sharp S
Conference: AAPS
Division: Simulations Plus

It is challenging to establish a standard approach for moving from preclinical to clinical phases of development. Many hurdles exist during formulation selection and for extrapolation of doses from animals to humans; what may have worked well for one drug candidate may not be appropriate for others. This presentation will provide a general framework/strategy to follow when moving from preclinical to clinical studies (FIH) based on risk identification and mitigation focusing on the application of mechanistic modeling and simulation (PBPK)​.