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Nov 10, 2020
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Simulation of first-in-human using an allometrically scaled population mechanistic TMDD model with preclinical monkey data

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

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