Physiologically Based Pharmacokinetics (PBPK)

A mechanistic modeling approach that simulates drug disposition using anatomical and physiological parameters (organ volumes, blood flows, tissue composition, enzyme expression) combined with drug-specific physicochemical and biochemical properties. PBPK models predict drug concentrations in individual tissues and organs, enabling prediction of drug-drug interactions, pediatric dosing, and the effects of organ impairment.

Ejemplos

• Simcyp Simulator — industry-standard PBPK platform (Certara)
• GastroPlus — PBPK with ACAT absorption model (Simulations Plus)
• FDA accepts PBPK modeling to waive clinical DDI studies