Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator without the need to run clinical studies
The Simcyp™ Simulator has been used by large pharma and innovative biotech companies to inform, reduce and/or replace clinical studies for 40 Kinase Inhibitor (KI) drugs in the past decade. This 20+ year in silico technology has been accepted by global regulators, not just in oncology, but also inflammatory, rare, neurology and other diseases. While best known for replacing drug-drug interaction studies, Simcyp is also used for formulation optimization, and to inform dosing in special populations, such as pediatrics, geriatrics, renal and hepatic impairment.
We’ve compiled insights showcasing how numerous pharma and biotech companies have successfully replaced clinical studies with the Simcyp Simulator. This innovative approach has not only predicted clinical outcomes but has also played a pivotal role in achieving label claims.
Key benefits
1.
Inform, reduce, and/or replace clinical studies
2.
Save time and money by using proven biosimulation technology
3.
Enhance key decision-making throughout drug development
