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.
Key learning points
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 and learn from our experts
Certara’s experts bring years of experience in PBPK modeling and virtual bioequivalence. Our Simcyp Simulator is the industry-leading tool for demonstrating VBE, with proven success in FDA approvals.
Download the white paper to learn how PBPK modeling can revolutionize bioequivalence, especially for complex generics.