Simulation of First-in-Human Using an Allometrically Scaled Population Mechanistic TMDD Model with Preclinical Monkey Data

Authors: Ayral G, Traynard P, Twarogowska M
Conference: ACoP
Keywords: first-in-human, MonolixSuite Playlist, PK data, simulx, TMDD model
Software: Simulx®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • 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