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 for fed BE studies remain persistent bottlenecks in generic drug approval timelines.

PBBM resolves all three — mechanistically.

How PBBM works

By connecting in-vitro dissolution data to whole-body pharmacokinetics through a validated physiological absorption model, PBBM answers the questions that classical dissolution statistics cannot:

Platform components

Our PBBM platform runs on:

PK-Sim® + MoBi® (OSP Suite v12) — mechanistic GI absorption, transit, pH-dependent dissolution, enzyme activity
Weibull IVIVC — Level A, B, and C in-vitro to in-vivo extrapolation, validated against clinical data
Biorelevant dissolution — FaSSIF, FeSSIF, USP pH 6.8 — three media simultaneously
Dissolution safe-space mapping — systematic simulation of dissolution spec ranges → BE probability heat maps
R automation layer — knitr/rmarkdown report generation, ggplot2 figures, all parametrised to your molecule

Regulatory frameworks we work within:

What the analysis delivers in under 2 hours:

A full PBBM package that would traditionally take 3–4 weeks through a large CRO now completes in under 2 hours on our platform — including figures, statistical outputs, and report text.

What drove us to build this?

We kept seeing Indian generic developers spending ₹25–40 lakhs and 6–8 months on clinical BE studies for molecules where the modelling evidence would have told the same story in days. The tools have been available — PK-Sim is free, the OSP suite is open-source, the FDA itself publishes the workflows. What was missing was a local team that had integrated them end-to-end and could deliver submission-quality outputs at Indian market speed and cost.

That’s what we built.

If your pipeline includes oral solid dosage forms with complex dissolution behaviour, BCS Class II/IV molecules, or products facing dissolution specification challenges — reach out. The first conversation is free. info@biopharmetrics.com

Frequently Asked Question?

What is Physiologically Based Biopharmaceutics Modelling (PBBM)?

Physiologically Based Biopharmaceutics Modelling (PBBM) is a mechanistic modelling approach that connects in-vitro drug dissolution data with in-vivo drug absorption and pharmacokinetics. It helps predict how formulation and dissolution changes may affect drug performance in the body and supports evidence-based pharmaceutical development decisions.

How can PBBM help generic drug developers with dissolution specification challenges?

PBBM helps assess whether differences in dissolution profiles between test and reference products may affect bioequivalence. It can define a dissolution safe space, evaluate formulation changes, and support the development of scientifically justified dissolution specifications, potentially reducing the need for additional clinical studies where appropriate.

Can PBBM modelling support biowaiver applications and regulatory submissions?

Yes. PBBM modelling can provide scientific evidence to support certain biowaiver applications, bioequivalence assessments, and regulatory submissions. Its suitability depends on the drug substance, formulation, model validation, available data, and applicable regulatory guidance. Regulatory acceptance is determined on a case-by-case basis.