In Vivo Extrapolation of Precipitation with Complex Dissolution Experiments

Authors: Mullin JM
Conference: AAPS
Keywords: dddplus, gastroplus, in silico in vitro–in vivo extrapolation (IVIVE), PBPK simulation
Software: DDDPlus™, GastroPlus®
Division: Simulations Plus

Session Description and Objectives

  • What is DDDPlus™​
  • How can it be utilized in drug development?​
  • What can DDDPlus predict?​
  • How do we use DDDPlus for complex precipitation assays?​
  • What results can be obtained?​
  • Case Study – synergy of DDDPlus and GastroPlus®​
  • Biphasic and membrane dissolution experiments for determination of precipitation kinetics.​
  • In Vitro to In Vivo (IVIVE) extrapolation of dipyridamole, ketoconazole, and itraconazole precipitation​
  • Why is precipitation important?​
  • What in vitro experiments can quantify precipitation rates?​
  • How can in vitro dissolution and precipitation can be modeled using DDDPlus?​
  • How can in vitro dissolution parameters translate into PBPK simulations and what are the pitfalls?

By James Mullin

Presented at American Association of Pharmaceutical Scientists (AAPS) PharmSci 360, October 17-20, 2021