기계론적 모델링 및 시뮬레이션의 견고한 기반 확보
Quantitative, model-based approaches to drug development have been identified by the FDA and other regulatory agencies as valuable tools to improve efficiency.
Our workshops focus on the optimal use of compound-specific in vitro and in vivo data, with system-specific information, to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drug (IND) and New Drug Applications (NDA) and assists with the optimal design and conduct of clinical studies. The ultimate aim is to improve the quality of submissions for regulatory approval.
These workshops provide a solid grounding in model-informed approaches and are not aimed solely at individuals who have hands-on experience. They are relevant to senior level managers as well as scientists working in the fields of drug metabolism, ADME, clinical pharmacology, pharmacokinetics, PBPK and PK/PD, in industry or in academia and research institutes.
For more information, please review the Simcyp Workshop FAQ.
Browse Upcoming Simcyp WorkshopsHear from Our Participants:
Comprehensive Knowledge: “The workshop provided comprehensive knowledge of physiological PBPK modeling using the Simcyp Simulator. The exercises that were beneficial to gain hands on experience.” Konstantina Koliopoulou
Ease of Material: “The material was easier to go through compared to concentrated workshops.” Aurelija Radzeviciene
Real-World Application: “Participating in this workshop focused on PBPK modeling with Simcyp offered a multitude of positive aspects that could greatly benefit my research project. The hands-on experience was invaluable as it allowed me to apply theoretical knowledge to real-world scenarios, enhancing my proficiency and confidence in using PBPK models.” Laura Olivo
On-site Education
The Simcyp on-site education program provides bespoke training sessions at your site. The program caters to small groups of scientists with specific training requests , through to larger workshop-style sessions. We can incorporate:
- Introductory or specialized simulator training
- Focused workshops covering key topics, and current trends in model-based drug development
- Professional guidance through hands-on exercises with practical applications of the simulator
- Face-to-face support for internal Simcyp working groups
Video Tutorials, Demos and Tips
We have video tutorials on various aspects of Simcyp Science and provide demos and practical tips for using the Simcyp Simulator. This material serves as a refresher for experienced users as well as an introduction for new users.
This resource is available through the Simcyp members’ area, which also includes. recordings of recent webinars and the Simcyp free ADME tools. The e-learning program is restricted to Simcyp Simulator users and Simcyp Consortium member companies.
Bastek leads the development of dermal models at Simcyp and cardiac safety modeling and simulation system – Cardiac Safety Simulator. He is also a tenured Professor in Biopharmaceutics at the Faculty of Pharmacy at Jagiellonian University in Krakow, Poland.
Dr. 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.
Iain leads the science team that is responsible for further developments of the population based physiologically-based PK/PD simulators to meet the needs of Simcyp Consortium members. Prior to joining Certara, he spent 12 years working in the Pharmacokinetics, Dynamics and Metabolism Department at Pfizer Global Research & Development.
Bastek leads the development of dermal models at Simcyp and cardiac safety modeling and simulation system – Cardiac Safety Simulator. He is also a tenured Professor in Biopharmaceutics at the Faculty of Pharmacy at Jagiellonian University in Krakow, Poland.
Dr. 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.
Iain leads the science team that is responsible for further developments of the population based physiologically-based PK/PD simulators to meet the needs of Simcyp Consortium members. Prior to joining Certara, he spent 12 years working in the Pharmacokinetics, Dynamics and Metabolism Department at Pfizer Global Research & Development.
