在机制建模和仿真领域打下坚实的基础
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 WorkshopsOn-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.
Sibylle’s areas of expertise are drug transport and non-CYP metabolising enzymes (e.g., UGTs). Thus, she has been involved in various projects including for instance the permeability-limited models (SIVA, ADAM, PerL, and the 4Brain model as well as Mech KiM). She has also been involved in the developed of several compound files for the Simulator (digoxin, rosuvastatin, pravastatin, cyclosporine, etc.).
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.
Sibylle’s areas of expertise are drug transport and non-CYP metabolising enzymes (e.g., UGTs). Thus, she has been involved in various projects including for instance the permeability-limited models (SIVA, ADAM, PerL, and the 4Brain model as well as Mech KiM). She has also been involved in the developed of several compound files for the Simulator (digoxin, rosuvastatin, pravastatin, cyclosporine, etc.).
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.
