Waiving Clinical Studies and Accelerating Drug Development for Kinase Inhibitor (KI) Drugs

Explore how Simcyp delivered benefits during multiple stages of the drug cycle, with these information-rich case studies from Certara.

Read now for insights into:

US FDA’s citing of ibrutinib (Imbruvica) example as the best practice for use of PBPK (Simcyp)
Simcyp Simulator’s ability to predict outcomes for a compound with complex, time-dependent,
non-linear PK
Simcyp PBPK simulations relied on for CYP DDI predictions over clinical results
Simcyp’s use in supporting approval of first-in-kind and only treatment for rare pediatric disease
Examples of how >10 clinical pharmacology studies were replaced by PBPK simulations in final drug label
New capabilities for Simcyp; predicting interpatient variability in patients with co-morbidities

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