How Novartis used Simcyp to support 14 FDA-approved novel drugs
Physiologically-based pharmacokinetic (PBPK) models are an integral part of mechanistically understanding drug absorption, distribution, metabolism, and excretion (ADME). When integrated into drug development, PBPK modeling can inform and broaden the product label, provide context for observed data, and create testable hypotheses.
Novartis has applied PBPK modeling for more than two decades to support a broad range of development and regulatory decisions, including:
- Supporting clinical trial design
- Informing pediatric starting dose
- Understanding the impact of other drugs, genotype or disease on drug exposure
- Informing different dosing regimens
- Providing dosing strategies in different populations
- Predicting complex drug-drug interactions
- Subsidizing and waiving clinical trials
Importantly, PBPK modeling has been used during regulatory review to inform the product labels of Novartis’ marketed products. To date, PBPK modeling has influenced over a dozen product labels at Novartis.
In this webinar, case studies from Novartis will be presented to demonstrate how PBPK strategies implemented using Simcyp informed key development decisions, accelerated drug development, and reduced development costs.
