Description
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.
Objectives
Delegates will learn how to simulate and predict:
• Metabolic drug clearance (CL)
• Metabolic drug-drug interactions (DDIs)
• Gut first-pass metabolism
• Oral drug absorption incorporating food effects and the impact of dosage form
• Effect of transporters and enterohepatic recirculation on kinetics and DDIs
• Drug distribution to different organs
• Population variability in drug concentration-time profiles
• Variation in kinetics in specific populations (pediatrics, ethnic groups, various disease populations)
• Modeling of therapeutic proteins
• Pharmacodynamic effects of different compounds
• Time-course of drug in plasma that fits observed clinical data (achieved by combining fitting techniques with IVIVE, PBPK and drug-specific in vitro data)
Certificate
By completing/passing this course, you will attain the certificate 5 Day Full Workshop IN PERSON
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