Model-informed Drug Development Intensive Interactive Courses

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Lectures in Japanese Intensive 5-day Workshop on Model-informed Drug Development - August 5-9, 2024  Venue: TKP Tokyo Station Conference Centre Early Registration Rate   January 22nd – March 26th 2024  GBP £3780 Regular Registration       March 27th – June 20th 2024        GBP £4500 Late Registration             June 21st – July 22nd 2024           GBP £5400 大手製薬会社を中心に、医薬品開発の様々な側面で、モデルを用いたアプローチの活用が進んでいます。 Simcypのワークショップは、in vitro, in vivo試験から得られる各薬物固有の性質と、様々な被験者集団に固有のデータを的確に統合して薬物動態をシミュレーションし、対象とする集団における薬物の挙動を理解することにフォーカスしています。このようなモデルに基づくアプローチにより、医薬品開発における意思決定に必要な情報提供し、臨床試験の実施及び試験デザインの最適化することが可能となります。 開発品のPK/PDを十分に理解し、開発期間とコストを削減するとともに、承認申請の質を向上させPrecision Medicineを実現することを目指しています。 Read more

This Workshop will take place in Princeton NJ, USA October 14-18, 2024 VENUE: HYATT REGENCY PRINCETON, 102 Carnegie Center,  Princeton, NJ 08540, US HOTEL: Bedrooms can be booked at - coming soon  LAPTOP: Delegates are required to bring a laptop computer, and will be provided with access to the Simcyp Simulator via Amazon Workspaces for the duration of the course.  COURSE MATERIAL: will be provided electronically via LearnUpon  COURSE COST:  £3,780          7th February to 20th June £4,500           21st June to 22nd August £5,400           23rd August to 7th October Incorporating population variability into mechanistic prediction of PK and modeling PK/PD The model-informed approach to various aspects of drug development is rapidly being adopted by the leading pharmaceutical companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drugs and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions, and eventually implement precision medicine. Read more

Broadening the range and utilization of in silico-based mechanistic prediction and analysis of drug absorption after non-oral application. Mechanistic modeling of the topical drug application, development of mechanistic physiologically-based in vitro-in vivo correlations (IVIVCs), and virtual bioequivalence (VBE) concepts. Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

Certara UK Limited is running a Simcyp hands-on workshop discussing the changes to pharmacokinetics during pregnancy and the prediction of pharmacokinetics (including in the milk) during lactation. Population based Physiologically Based Pharmacokinetic (PBPK) approach will be utilized to describe the pharmacokinetics during pregnancy and lactation and to determine population variability. The major topics covered are: Maternal and fetal gestational age-dependent physiological changes Prediction of maternal and fetal drug pharmacokinetics Ways of incorporating ex vivo experimental data on transplacental kinetics within the PBPK model Handling gestational age-varying covariates during simulation Prediction of PK in breastfeeding mothers and milk exposure using lactation models Prediction of infant dose for breastfed infant This course will be run using the Amazon Workspaces in Cloud; please ensure you have access to a computer.   Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

November 11-15, 2024 | ONLINE Predicting age related changes to pharmacokinetics (PK) and drug-drug interactions including associated variability—linking this information to drug response in the pediatric population. Participants will learn how PK behavior can be modeled in preterm and term neonates, infants, and children and how it can be linked to predict the drug response (PD) within the PBPK platform. Hands-on exercises explore how this valuable information is relevant to early and informed decisions to assist in the improved design of pediatric clinical studies. Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

November 11-15, 2024 | ONLINE The ABC of modelling drug transporter data: Mechanistic approaches to predict the impact of drug transport proteins on ADME, Pharmacokinetics, and Toxicity Overview: This course provides a dynamic mixture of lectures, demonstrations and hands-on exercises providing a wide-array of theory and practical know how. Live demonstrations of the simulation platforms essential for consideration in developing PBPK models with transporters are given, which will facilitate the attendees learning, driven through hands-on sessions to be attempted remotely. The hands-on sessions will be re-visited the following day with the tutors providing guidance, troubleshooting tips and facilitating interactive Q&A on the exercises. Live Online Courses There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund. Read more

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