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WHITE PAPER

Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development

Do expensive bioequivalence studies stall your generic drug pipeline?

Unlock the secrets to streamlined generic drug approval with our expert-authored white paper. Discover how physiologically-based pharmacokinetic (PBPK) modeling can revolutionize your approach to demonstrating bioequivalence, especially for complex generics.

Virtual Bioequivalence (VBE) leverages advanced computer modeling to simulate drug behavior in the body, offering a powerful alternative to traditional clinical bioequivalence studies.

What you'll learn

The current landscape of complex generic drug development

The advantages of using Virtual Bioequivalence over traditional clinical bioequivalence studies

How PBPK modeling supports Virtual Bioequivalence

FDA’s perspective on model-integrated evidence for generics

Strategies for dermal products, long-acting injectables, and BCS Class III drugs

The power of Simcyp’s MPML MechDermA™ model

Learn why Virtual Bioequivalence is the way forward for Complex Generic Drug Development

Cost-effective alternative to clinical bioequivalence studies
Accelerated development timelines for complex generics
Improved understanding of drug-formulation interactions
Enhanced decision-making in generic drug development
Increased confidence in demonstrating bioequivalence

FDA Encourages Modeling & Simulation for Generic Drug Approvals

The FDA is actively encouraging modeling and simulation to support generic drug approvals. Stay ahead of the curve and gain a competitive edge in generic drug development.

Download the white paper

Download the white paper to learn how PBPK modeling can revolutionize bioequivalence, especially for complex generics.

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.