|Who should attend?
The course is suitable for Drug Discovery & Development Scientists e.g. pharmacologists, medicinal chemists, safety and clinical scientists, statisticians, pharmacokineticists, etc. The course is also of value to regulatory experts.
• To raise awareness amongst bioscientist, medicinal chemists and clinical scientists of what kinetic dynamic (PKPD) methods can offer
• To raise awareness of the individual steps that make up the dose-plasma-distribution-binding-turnover-response process
• To raise awareness of experimental design. Which investments have to be made early and late in discovery?
• To build a case for the assessment of the first time in man dose
• To provide theory and methods of in vivo PK & PD data using MAXIM2 as a simulation tool
”MAXSIM2 is an easy to use, intuitive, and interactive application for physiologically based pharmacokinetic and pharmacodynamic (PPKPD) simulation developed at the Fraunhofer-Chalmers Research Centre for Industrial Mathematics (FCC) in close collaboration with Dr. Johan Gabrielsson. The simulation models in MAXSIM2 are physiologically based, which means that the pharmacokinetic and pharmacological processes are defined in terms of physiologically, anatomically, and biochemically interpretable parameters and mechanisms. In thesemodels each organ is represented by one or several compartments, which are interconnected by blood flow. These types of models are excellent tools for real-time presentation of the interplay between physiology, pharmacology, and pharmacokinetic processes. MAXSIM2 also includes a variety of pharmacodynamic models, such as instantaneous concentration-response models, distributional models, and turnover models. MAXSIM2 is an ideal application for both educational and commercial use where thorough understanding of pharmacodynamic and pharmacokinetic phenomena is important”.
Delegates must bring their own laptops to the course.
Equilibrium data and models
||Introduction and mental contract|
• What are our expectations
• Course layout & course material
|| Lecture 1 Review of basic PK concepts|
* Review of CL, Vss & t1/2 from a PD point of view
* IV vs extravascular dosing
* Review of basic PPB concepts Cu, C & fu
* When does plasma protein binding matter?
* Steady-state exposure
||Lecture 2 Pharmacodynamics A (Equilibrium) |
* Efficacy, potency, specificity and selectivity
* Review of Steady-state models
* Kinetics of drug action
* Design issues and Case Studies
||Lecture 3 Inter-species scaling|
* Review scaling & allometry from a PD point of view
* Why animals differ wrt turnover of drugs
* Why do we build a dose nomogram?
||Group exercise(s) I|
* Prediction of the human dose from PKPD data
* Exercise with the Maxsim2 program
|Wrap-up of the day and the group exercise |
Time delays (Temporal differences)
||Lecture 4 Pharmacodynamics B (Time delays)|
* Steady-state models vs. time delay
* Basic concepts on distributional delays
* Turnover concepts and how to model
* Design issues and Case Studies
Lecture 5 Case Studies
* Project example(s)
* Summarizing the effective concentration range
* Dose nomogram
||Groups exercise(s) II |
• CD Selection of human dose from PK/PD data
||Summary of Group exercise |
|Wrap-up of course|
||• Pharmacokinetics from a pharmacological point of view
• PK half-life vs. half-life of response
• The apparent disconnection between concentration and response
• Effect compartment models (distribution-rate limited)
• Turnover models (indirect response)
• Receptor on/off binding models
• Scaling PK and PD properties to man
• Practical experimental design of PD studies
• PK&PD assessment at milestone decisions
Johan Gabrielsson has been Senior Principal Scientist at AstraZeneca R&D Mölndal. His responsibilities included kinetic/dynamic related project tasks in the CV & GI & CNS & Cancer & Biologics areas. He is author of the textbook ‘Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications’ 4th ed. (2006). He is professor of Integrative Pharmacology at the Swedish Agricultural University in Uppsala, Sweden. He is also academically affiliated with Dept. of Pharmaceutics, Univ. Tennessee and University of Manchester. He has published extensively in the field of pharmacokinetic-pharmacodynamic modelling and reasoning, and has run numerous courses internally and externally in the area of biological data analysis since 1985 in Europe, the US and Asia (>4000 participants) at both the undergraduate and graduate level. His research focuses on modelling different aspects of endogenous turnover, such as functional tolerance and rebound phenomena, physiological limits and target-mediated drug disposition in collaboration with Professor LA Peletier, Leiden University. He has been external examiner on several PhD Theses abroad.
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|Time and Location
This course will take place on September 11-12, 2013 at the Maritim Hotel München which is located only a 10-minute walk from the central train station, it's also close to the city’s most famous historical landmarks. In addition to these renowned sightseeing attractions, the hotel’s immediate neighborhood is dominated by an inspiring multicultural atmosphere. Turkish shops offer fresh fruit and vegetables for bargain prices and all sorts of exotic gifts for travelers.
|Application, Confirmation, Cancellation etc
The participation fee is EUR 1350 (All prices are VAT exclusive and VAT 25% will be added). The fee includes course documentation, coffee, lunches and a course dinner.
A number of hotel rooms have been booked at the Maritim Hotel München at preferential rates between Tuesday, September 10 – Thursday, September 12, 2013. The price for a single room is EUR 140/night (VAT exclusive) including breakfast.
Delegates will be registered upon receipt of the completed form and a first confirmation will be sent by e-mail.
The number of seats are limited and early booking is strongly recommended.
Detailed course information will be sent out approximately two weeks before the event. An invoice will be sent separately and the payment must be settled before the start of the course.
Cancellations should be addressed, in writing, to Annica Flodin at the Swedish Academy of Pharmaceutical Sciences Annica.Flodin@Lakemedelsakademin.se
• Cancellation can be made free of charge until July 28, 2013
• No refunds will be made after July 28, 2013
Substitutions may however be made at any time. Kindly forward the name of the substitute to Annica.Flodin@Lakemedelsakademin.se