Physiologically Based Biopharmaceutics Modelling (PBBM): An Automated Platform for Regulatory Submissions
Physiologically Based Biopharmaceutics Modelling (PBBM): An Automated Platform for Regulatory Submissions Introduction 🔬 Announcing our second new capability: Physiologically Based Biopharmaceutics Modelling (PBBM) — in-house, automated, and built for regulatory submissions. The Indian pharma industry generates the largest number of ANDAs filed to the USFDA globally. Yet dissolution specification failures, f2 mismatches, and the need […]
Virtual Bioequivalence (VBE): An In-House Platform for Faster Bioequivalence Analysis
Virtual Bioequivalence (VBE): An In-House Platform for Faster Bioequivalence Analysis Introduction to Virtual Bioequivalence Biopharmetrics Consultants is now equipped to deliver Virtual Bioequivalence (VBE) analysis — powered by an in-house platform we built from the ground up. For years, demonstrating bioequivalence has meant designing expensive clinical trials, recruiting subjects, and waiting months for results. For […]
Revolutionizing Drug Development: The Power of Model-Informed Approaches
Revolutionizing Drug Development: The Power of Model-Informed Approaches Introduction to Model-Informed Drug Development Model-Informed Drug Development is a game-changer in the pharmaceutical industry, utilizing mathematical models to optimize drug development processes. These models revolutionize the way we predict drug efficacy and safety, optimize dose selection, and understand drug-drug interactions. What is Model-Informed Drug Development? Model-Informed […]
