Tech-driven Services and Software
With more than 90 novel drugs that leveraged Simcyp for approval and scores of other drugs for which Simcyp answered key regulatory and development questions, a list of key applications include:
- 약물 간 상호작용 시뮬레이션 – 유발 약물과 영향 약물
- 흡수 모델링 – 제형 효과/생물학적 동등성, 음식물의 영향
- 특수 집단을 위한 용량 – 소아, 노인, 장기 손상, 질환 상태, 인종 차이
- 외인성 요인에 의한 약물 효능 평가 – 흡연, 알코올
- 새로운 투여 경로 – 피부, 진피, 지속성 주사제
- 생물학적 제제 – mAb, ADC, 기타 단백질, 사이토카인 매개 DDI
- 가상 생물학적 동등성 및 제형 복합 제네릭 의약품용
- 조기 PK 예측, FIH 용량
Immunogenicity (IG), the ability of a therapeutic product to trigger an immune response in the body can be ‘desired IG’ to support vaccine and allergen response or ‘undesired IG’ causing immunologically related adverse events. Certara’s QSP team has developed a regulatory-ready software platform (Simulator) for managing both wanted and unwanted IG, a pivotal tool to guide clinical and regulatory decision-making in drug development. QSP can provide insight early in the development process (for example, predicting IG from protein sequence alone or extrapolating from pre-clinical assays) and ultimately be used to leverage vast amounts of biological and pharmacological data to address larger challenges such as phase 2 failures.
In short, QSP enables the understanding of disease pathophysiology to identify and test therapeutic strategies in virtual trials with virtual patients.
Our Simcyp COVID-19 Vaccine Model has won an R&D 100 Award, which recognizes the top 100 “R&D pioneers and their revolutionary ideas in science and technology” in the past year. The model, which is incorporated in Certara’s Vaccine Simulator, has been used by major pharmaceutical companies and allows researchers to study how a vaccine is handled by the human body in computer-generated, virtual populations.
Piet van der Graaf, PharmD, PhD
Piet은 Sanofi와 Pfizer의 제약 산업에서 20년 넘게 근무한 경험을 통해 QSP 프로젝트에 있어 상당한 기술과 경험을 제공하며 Certara의 전략적 개발에 기여합니다. 또한 그는 CPT의 편집장이기도 합니다.
Hannah Jones, PhD
Hannah has over 18 years experience in global pharmaceutical organizations, possessing a particularly strong background in PBPK and PKPD modelling, She has over 50 publications in PBPK/PKPD modelling and other DMPK related topics, and considerable experience influencing drug research and development programs through modelling and simulation.
Karen Rowland Yeo, PhD
2002년부터, Karen은 인간의 생체 내 약동학을 예측하기 위한 생체 외 데이터 외삽과 관련된 프로젝트를 이끌었습니다. 여기에는 Simcyp Simulator에 대한 모델 개발 및 구현이 포함됩니다. 또한 그녀는 생리학 기반 약물동태 및 약물 간 상호작용 예측을 비롯한 특정 연구 분야에 관심이 있습니다.