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PBPKモデリング&シミュレーションのトレーニング

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. 当アプローチの究極の目的は、規制当局における承認申請文書に記載される情報の品質を最大化させることにあります。

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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オンサイト教育

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
  • Simcyp 参加者グループごとの対面サポート
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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.

詳細を表示
Bastek Photo
Sebastian Polak, PhD Senior Scientific Advisor & Head of Mechanistic Dermal Modelling

Simcypの皮膚モデル、心臓安全モデリング&シミュレーションシステムCardiac Safety Simulatorの開発を主導。また、ポーランド・クラクフのヤギェウォ大学薬学部で生物薬剤学の終身教授を務めています。

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 Sr. Scientific Advisor and Head of Translational Science.

Iainは、Simcypコンソーシアムメンバーのニーズを満たすために、集団ベースの生理学的ベースのPK/PDシミュレータのさらなる開発を担当する科学チームを統括しています。サターラ入社以前は、ファイザーのグローバル研究開発部門の薬物動態・動態・代謝部門に12年間所属していました。

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