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

Authors: Suarez-Sharp S
Conference: AAPS
Keywords: AAPS 2022, clinical, fih, FIHSimulator, modeling and simulation, pbbm, PBBM modeling, PBPK, preclinical
Division: Simulations Plus

Objectives

  • To emphasize the relevance of cross-functional multidisciplinary collaboration for successful transition from preclinical to clinical studies​
  • To describe data collection considerations on drug product quality, biopharmaceutics, preclinical and clinical testing strategies, as well as study design on the conduct of FIH studies (small molecules)​
  • To discuss the principles on the calculation of the starting dose to be used in humans, the subsequent dose escalations, the criteria for maximum dose and the conduct of the trial inclusive of multiple parts​
  • To list strategies for risk assessment and mitigation ​
  • To illustrate the relevance of PBPK models on streamlining the transition  from preclinical to clinical phases and its contribution in accelerating the drug product development process​

By Sandra Suarez-Sharp

Presented at American Association of Pharmaceutical Scientists (AAPS) Pharm Sci 360 Boston, Massachusetts October 16-19, 2022