It’s hard to imagine that 37 leading, global biopharmaceutical companies would be willing to partner to develop a new technology and progress a scientific field, but that is exactly what the members of the Simcyp Consortium have achieved. Working together in a pre-competitive, collaborative research environment, the consortium’s members are advancing physiologically based pharmacokinetic (PBPK) … Continued
Tag: PBPK Modeling & Simulation
Version 19 offers mechanistic models for assessing maternal-fetal drug risk, developing drug formulations, and optimizing dermal and transdermal drug development
This webinar will explain lessons learned from preparing for and responding to viral outbreaks such as H5N1 and pH1N1 influenza and discuss how insights from model-informed drug development approaches can spur access to medicines for patients.
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The … Continued
This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.
PRINCETON, NJ – Jan. 8, 2020 – Certara’s Simcyp® Simulator’s MechDermA™ model provided safety label claim and pediatric dosing information without the need for testing in clinical patients for a topical drug product.
PRINCETON, NJ – Dec. 10, 2019 – LEO Pharma has licensed Certara’s proprietary Simcyp®️ Population-based Simulator and joined its Consortium.
This webinar explained how the latest updates in the Simcyp Simulator v19, Certara’s physiologically-based pharmacokinetic (PBPK) modeling and simulation platform, will support developing safer, more effective medications faster.