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DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare B-cell malignancies to market.  The company leveraged FDA’s accelerated approval program; it was one of the first to be awarded breakthrough status by the agency. Ibrutinib is susceptible to interactions with a strong inhibitor and inducer of CYP3A4 enzymes, thus … Continued

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