Prediction of midazolam pediatric plasma profiles for multiple routes of administration using physiologically based pharmacokinetic model

Authors: Le Merdy M
Conference: GMP
Keywords: ADME, drug development, PBPK, PBPK modeling, pediatrics
Software: ADMET Predictor®, GastroPlus®
Division: Simulations Plus

Talking Points

  • Owing to ethical and logistical constraints, clinical investigation of drugs in the pediatric population is challenging
  • Physiologically based pharmacokinetic (PBPK) modeling because of its ability to facilitate age-dependent extrapolation of data can be a valuable tool in pediatric drug development
  • PBPK combined with mechanistic absorption models validated against adult datasets can describe API ADME in pediatrics for multiple routes of administration