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.
