概述
Simcyp® Simulator is the industry-leading physiologically-based pharmacokinetic (PBPK) platform developed over 25 years in collaboration with a consortium of more than 35 leading pharmaceutical companies worldwide. It is the first and only EMA Qualified PBPK platform for three contexts of use and is widely used to support critical R&D decisions and regulatory submissions, including label claims in lieu of clinical studies.
Simcyp Simulator’s key features include:
- Extensive libraries on demographics, developmental physiology, and drug elimination pathways
- Advanced mechanistic organ models and compound files
- Virtual population simulations across diverse demographics, ethnicities, and disease states
- Over 30 population libraries and more than 100 small and large molecule models
- Ability to support compound and population verification documents for regulatory submissions
In this webinar, Simcyp experts will provide an overview of the key features and highlight the latest scientific advancements in Version 25, demonstrating how ongoing R&D innovation keeps Simcyp at the forefront of PBPK modeling and helps teams increase certainty and accelerate timelines.
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Sibylle Neuhoff, PhD
Senior Scientific Advisor, Lead of the Transporter GroupDr. Sibylle Neuhoff is a Senior Scientific Advisor and Deputy Head of the Translational Science Group at Certara Predictive Technologies, where she leads the Transporter Group within Simcyp. With over 25 years of experience in the fields of transport, transporters, and their mechanisms, Dr. Neuhoff is a recognized expert in PBPK/PD modeling, oral drug absorption, transport, metabolism, and toxicity. Her extensive research is documented in numerous peer-reviewed journal articles (Sibylle Neuhoff (0000-0001-8809-1960) – ORCID).
Dr. Neuhoff holds a degree in Chemistry from the Goethe University in Frankfurt am Main, Germany, and earned her PhD from the Department of Pharmacy at Uppsala University, Sweden, in 2006. Her current research focuses on the pharmacogenomics of drug-metabolizing enzymes and transporters, drug disposition and pharmacodynamics, ligand interactions with human metabolizing enzymes and transporters, endogenous biomarkers, and innovative approaches to simulate and predict metabolic clearance, drug-drug interactions, and transporter-related interactions in both healthy subjects and patient populations.
Dr. Neuhoff has taught over 50 PBPK workshops on the Simcyp™ PBPK Simulator, Simcyp Animal, and the Simcyp In Vitro Data Analysis (SIVA) toolkit, covering topics such as MIDD, Transporter, FIH, DDI, and Best Practices. She is regularly invited as speaker to present at national and international conferences and meetings.
Additionally, Sibylle is an active member of The International Transporter Consortium.
Felix Stader
Senior Research Scientist at Certara UK Limited, Simcyp DivisionFelix studied biology and pharmaceutical science in Muenster (Germany) and did his PhD in Basel (Switzerland) about HIV drug pharmacokinetics and drug-drug interaction magnitudes in the elderly by using a Matlab model. At Certara UK, he worked extensively on the biologics models of the Simulator including subcutaneous absorption, antibody-drug conjugates and the possibility to simulate therapeutic protein disposition in paediatrics. Additionally, Felix has broad experience in developing population and compound files.
Masoud Jamei, PhD
Senior Vice President, Simcyp Research & Development, CertaraJamei 博士领导着一个由大约 50 名科学家和 35 名软件开发人员以及测试人员组成的团队，专注于 Simcyp 软件的设计、开发和实施。
高级首席科学家
Associate Principal Scientist
Principal Scientist
Senior Research Scientist
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