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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.

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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
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On-site Education
Video Tutorials, Demos and Tips

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.

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Bastek Photo
Sebastian Polak, PhD高级科学顾问兼皮肤机理模型负责人

Bastek 主导 Simcyp 皮肤模型和心脏安全建模与模拟系统 - 心脏安全模拟器的开发。他还是波兰克拉科夫 Jagiellonian 大学药学院生物制药学终身教授。

Sibylle
Sibylle Neuhoff, PhD Sr. Principal Scientist and deputy head of Translational Science

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.).

Bio Pic IanGardner
Iain Gardner, PhD高级科学顾问兼转化科学负责人

Iain 领导的科学团队负责进一步开发基于群体生理的 PK/PD 模拟器,以满足 Simcyp 联盟成员的需求。在加入 Certara 之前,他在辉瑞全球研发部的药物动力学、动力学和代谢部门工作了 12年。

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