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PK Submit automates the time consuming, error-prone and complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. It allows you to automatically create a complete electronic regulatory submission-ready package within minutes during the normal process of setting up and executing a non-compartmental analysis (NCA).
Children, the elderly, pregnant women, and other different populations may need different medication and vaccine doses to optimize safety and efficacy. But using conventional clinical trials to determine dosing for different populations can be difficult for ethical and logistical reasons. Virtual patients that vary physiologically can be used to understand how new vaccines and medicines … Continued
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.