Milestone Achieved: Simcyp 100
つまり、規制当局が認めたSimcypシミュレータの予測により、これらの100新薬のスポンサーは、薬剤ラベルに処方情報を追加することが可能となり、コストと時間のかかる臨床試験をPBPKの活用によって省略することができます。同時に、その薬剤の潜在的な患者集団を拡大することができます。
Clinical Trial Waivers
These 100 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が活用された新薬100種
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 >325 individual label claims for these 100 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 10 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 100, with regulatory acceptance of PBPK in lieu of clinical studies from the following agencies:
- 米国FDA
- EMA
- UK MHRA
- Australia TGA
- カナダ保健省（Health Canada）
- Japan PMDA
