By Ellen Leinfuss AAPS PharmSci 360 meeting took place virtually over the past week. Not to be too ‘punny,’ but virtual drug development using mechanistic modeling took a prominent role on the agenda. Fittingly (sorry, I am on a roll), the Simcyp Simulator accounted for 10 posters in the Physiologically-Based Pharmacokinetic (PBPK) group—leading the category. … Continued
Patients often take more than one drug at a time, especially elderly patients and those with complex diseases, such as cancer and neurological disorders. Therefore, it is crucial to determine what the potential risk might be of a new drug candidate interacting with existing marketed medications. …
Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US FDA’s accelerated approval programs, the company generated PBPK models using the Simcyp Simulator to inform dose, dosing regimens, and DDIs. Approved initially for mantle cell lymphoma as a breakthrough therapy, Imbruvica is now approved for multiple uses, including first-line CLL.
Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This review provides a brief account of the current knowledge, practices, and opinions on MIPD while defining an achievable vision for MIPD in clinical care … Continued
Safety issues account for about a quarter of the attrition in drug projects, and can arise from either the primary or secondary pharmacology. ToxStudio™ is an integrated modelling & simulation platform for safety pharmacology and toxicology, facilitating quantitative translation from in vitro and in vivo data. Its first module, Secondary Intelligence™, manages and visualizes secondary … Continued
