13 Nov 2024
Join Crystal Pharmatech Subject Matter Expert, Ridwan Islam, M. Pharm., Ph.D., at MIDD+ Boston, hosted by Simulations Plus, Inc. on May 6-7.
Register for scientific presentations and hands-on learning at: https://lnkd.in/eUefupXz
Utility of PBPK Modeling as Step 1 in a 3-Step First Time Right Crystal Pharmatech Formulation
Abstract:
PBPK modelling is a valuable tool to address a much wider range of pharmaceutical applications besides drug-drug interactions. We present here PBPK modeling applications routinely used at our CDMO for in-vitro to in-vivo translation and pharmacokinetic modelling in preclinical species in addition to first-in-human pharmacokinetic predictions.
Linking of in-silico quantitative structure–property relationship models with (PBPK) modelling is Step 1 of a tailored Formulation for Phase I. Combined with parameter sensitivity we can clearly identify the key compound API Form and Formulation properties.
This leads to the fastest, most efficient formulation development with visibility into future clinical trials.