PharmaPrimes provides Model-Informed Drug Development services integrating Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modeling (PBBM) with Virtual Bioequivalence simulations using GastroPlus®.
These approaches integrate in-vitro data, API physicochemical properties, formulation characteristics, physiological parameters, and available clinical pharmacokinetic data to support pharmaceutical development and bioequivalence strategy.
Modeling is applied where it is scientifically relevant to the development question.
Potential inputs:
Integration of drug, formulation, dissolution, and physiological information into a mechanistic model.
Comparison of simulated PK profiles with appropriate observed clinical data where available.
Simulation of virtual populations and prediction of plasma concentration-time profiles.
Statistical assessment of relevant PK parameters, particularly Cmax and AUC.
Modeling and simulation are performed using GastroPlus®.
Integrated clinical and bioanalytical support for BE/BA studies and pharmacokinetic evaluation.
Formulation development, process development and optimization, analytical method development and validation, stability studies, regulatory documentation support, and pharmaceutical dossier assessment.
Scientific and regulatory support including pharmaceutical dossier assessment, CTD documentation support, scientific justification, and regulatory submission support.
Tell us about your formulation, available data, and development question, and our modeling team will outline a suitable PBPK/PBBM or VBE approach.
