Milestone Achieved: Simcyp 100
这意味着监管机构接受的来自 Simcyp Simulator 的预测使这 100 种新药的申办方能够在药物标签上添加处方信息，从而避免了昂贵和耗时的临床研究，同时也扩大了该药物所适用的潜在患者人群。
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.
了解 Simcyp 100
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:
- 美国食品药品监督管理局
- EMA
- UK MHRA
- Australia TGA
- 加拿大卫生部
- Japan PMDA
