Preclinical PBPK Model Translated for Human Exposure Prediction

Biopharmetrics employs rigorous validation methods to ensure the accuracy and reliability of predicted human pharmacokinetic (PK) profiles derived from preclinical PBPK models. One key aspect is the comparison of predicted human PK profiles against observed data from clinical studies, providing empirical validation of model predictions. Furthermore, extensive sensitivity analyses are conducted to assess the impact of varying model parameters and assumptions on predicted outcomes, ensuring robustness across different scenarios. Additionally, Biopharmetrics compares predictions generated using PBPK modeling against those obtained through other established methodologies like model-based allometric scaling (AS). This thorough validation process ensures that predicted PK profiles accurately reflect human physiological responses, enabling informed decision-making in drug development and dosage optimization.

Biopharmetrics leverages PBPK modeling as a powerful tool to facilitate decision-making in drug development and dosage optimization, enabling more informed and efficient processes. By integrating preclinical data and physiological knowledge into PBPK models, Biopharmetrics accurately predicts human exposure and pharmacokinetics, allowing for early identification of potential efficacy and safety concerns. These predictions aid in optimizing dosage regimens, guiding dose selection, and informing clinical trial design. Moreover, PBPK modeling enables virtual simulations of various dosing scenarios, facilitating the exploration of alternative formulations and administration schedules without the need for extensive and costly clinical trials. Overall, Biopharmetrics’ utilization of PBPK modeling enhances the efficiency and success rates of drug development programs, ultimately benefiting both patients and pharmaceutical companies.