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 generic drug developers — especially those working on modified-release, complex oral, or rare-disease products — that model is increasingly being challenged.
VBE changes the equation.
Platform and technology details
Instead of running a clinical BE study first, you simulate it. A validated PBPK model predicts plasma concentration-time profiles across a virtual population, computes GMR and 90% CIs, estimates statistical power, and tells you your recommended sample size — before a single subject is dosed.
Our platform is built entirely on open-source, regulatory-cited tools:
→ PK-Sim® v12 (OSP Suite) — whole-body PBPK modelling engine, FDA-cited, free, openly published
→ ospsuite.VBEToolbox (R) — the workflow package from Hamadeh et al., CPT:PSP 2025
→ NPOD algorithm — non-parametric Bayesian inference of inter-individual variability (IIV), no distributional assumptions
→ Custom R interface — connects all four steps: model input → NPOD inference → GMM virtual population → trial simulation → automated report
What the platform delivers:
- GMR point estimate + 90% CI for AUC and Cmax
- Power curves across n = 10–100 subjects
- Crossover, replicate, and parallel trial designs evaluated simultaneously
- Auto-generated Methods, Results, and Discussion text — submission-ready in < 30 minutes
- Compatible with FDA PSG library, ICH M13, EMA PBPK Q&A, and CDSCO ANDA requirements
The entire workflow — from a validated PBPK model to a draft regulatory report — runs in under 30 minutes. What previously required weeks of CRO engagement can now be iterated in an afternoon.
Who this is for:
Indian pharma companies with ANDA pipelines. Generic developers facing f2 failure or dissolution mismatches. Sponsors navigating FDA queries on formulation bridging. Any team that wants to know their BE outcome before committing to a clinical trial.
We serve clients across India and globally — US, EU, Asia Pacific.
If your team is working on a bioequivalence challenge — modified release, complex oral, fed BE waiver, post-approval change — let’s talk.
📩 Connect with me directly or reach us at info@biopharmetrics.com
Frequently Asked Question?
What is Virtual Bioequivalence (VBE) analysis?
Virtual Bioequivalence (VBE) analysis uses validated physiologically based pharmacokinetic (PBPK) models to simulate bioequivalence studies in a virtual population. It predicts plasma concentration-time profiles, estimates geometric mean ratios (GMR), calculates 90% confidence intervals, and evaluates statistical power and sample size before conducting a clinical study.
How can Virtual Bioequivalence modelling benefit generic drug developers?
VBE modelling helps generic drug developers evaluate potential bioequivalence outcomes before committing to clinical trials. It supports the assessment of modified-release formulations, complex oral products, and formulation changes, helping teams make more informed decisions about study design and development strategies.
Can Virtual Bioequivalence analysis support regulatory submissions?
VBE analysis can generate outputs relevant to regulatory assessments, including GMR estimates, 90% confidence intervals, statistical power calculations, and sample size recommendations. The suitability of these outputs for a specific submission depends on model validation, the product, and applicable regulatory requirements.
Our Recent Post
- Physiologically Based Biopharmaceutics Modelling (PBBM): An Automated Platform for Regulatory Submissions
- Virtual Bioequivalence (VBE): An In-House Platform for Faster Bioequivalence Analysis
-
Revolutionizing Drug Development: The Power of Model-Informed Approaches - Ensuring Safety in Dissolution Specifications: Creating a Safe Space for Success
- Physiologically Based Biopharmaceutical Modelling
