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Milestone Achieved: Simcyp 100

이는 Simcyp Simulator의 규제 승인 예측을 통해 이러한 100개의 신약의 의뢰자가 약물 라벨에 처방 정보를 추가할 수 있어 비용과 시간이 많이 소요되는 임상시험을 제거하는 동시에 해당 약물에 대한 잠재적 시험대상자 모집단을 확장할 수 있음을 의미합니다.

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.

Learn more about Simcyp Consulting services

Simcyp 100 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 >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
100+ novel drugs informed by Simcyp Simulator
Meet the Simcyp 100
The Regulators are on Board with PBPK

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:

  • US FDA
  • EMA
  • UK MHRA
  • Australia TGA
  • 캐나다 보건부
  • Japan PMDA
Watch the 1 minute video of the Simcyp 100

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