February 23, 2017 – Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
March 15, 2017 – This webinar describes how the Simcyp pregnancy-PBPK model was used to predict systemic exposure during pregnancy for three probe medications: metformin, tacrolimus, and ostelamivir.
March 29, 2017 – Learn how non-parametric approaches can be used to determine time scaling for in vitro-in vivo correlation (IVIVC).
April 26, 2017 – The scope of Physiologically-based Pharmacokinetic (PBPK) modeling can be expanded by assimilating mechanistic models of intracellular processes from the Systems Biology field. Genome Scale Metabolic Networks (GSMNs) represent whole sets of metabolic enzymes expressed in human tissues. Dynamic models of the gene regulation of key drug metabolism enzymes are also available. Here, we will introduce GSMNs and review ongoing work on integrating PBPK, GSMNs and metabolic gene regulation. We demonstrate example models.