Simcyp 120+
The regulatory-accepted predictions from the Simcyp Simulator have allowed sponsors of over 120 new drugs to include prescribing information directly on the drug label. This advancement eliminates the need for expensive and lengthy clinical studies, while also broadening the potential patient population for these drugs.
Clinical Trial Waivers
These 120+ drugs collectively saved their sponsors at least $100 M by using Simcyp versus running clinical studies, while also providing important prescribing information.
Extrapolation to Special Populations
While many sponsors use Simcyp to first address DDIs, that same PBPK model can then be applied to additional R&D questions—ranging from alternative formulation or routes of administration options—to predicting outcomes for untested populations such as pediatrics and organ impaired.
Reduce Sample Size
Oftentimes, Simcyp is used alongside in vivo clinical studies, to optimize patient selection and/or to justify the least number of participants necessary to predict clinical outcomes and attain a label claim.
Simcyp 120 살펴보기+
The Simcyp Simulator delivers unquestionable value for the development of small molecule oncology drugs, but has also been successfully applied to both small and large molecule drugs in areas such as rare disesase, CNS, gastroenterology, endocrine disorders, dermatology and infectious disease.
Using the Simcyp Simulator as a part of the development program has resulted in >400 individual label claims for these 120+ novel drugs, including:
- DDI perpetrator
- DDI victim
- Pediatric population (neonate through age 17)
- Drug CYPs and transporters
- Gastric acid reducing agents
- Renal impaired population
- Hepatic impaired population
- Diseased populations
The Regulators are on Board with PBPK
In the past 15+ years, global regulators have increasingly been assessing the benefits of PBPK in drug development, resulting in dozens of draft and final guidance documents, position papers, workshop presentations and peer-reviewed publications outlining its many applications. That work has fueled the Simcyp 120+, with regulatory acceptance of PBPK in lieu of clinical studies from the following agencies:
- US FDA
- EMA
- UK MHRA
- Australia TGA
- 캐나다 보건부
- Japan PMDA