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| Meals & Accommodation |
Accommodation four nights (Sunday October 20- Thursday Otober 24, 2013) breakfasts, lunches, coffee breaks and one dinner are included in the participation fee.
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| Course Secretary |
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The workshop is intended for individuals engaged in the pharmaceutical industry, regulatory agencies, contract research companies and universities, and for others who want to learn the aspects of model fitting. Previous participants have been toxicologists, kineticists, bioanalytical chemists, pharmacologists, clinical pharmacologists, anesthesiologists, clinical research assistants, and scientists from academia and regulatory agencies. Participants should have a background in pharmacokinetics, but those with limited experience would also benefit. The number of participants is limited.
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Euro 3300, before June 1, 2013. From this date the fee is Euro 4000. (All prices are VAT exclusive and VAT 25% will be added).
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Monday
Introduction
Introduction and overview
Introduction to nonlinear regression
Introduction to WinNonlin
Introduction to Hands-on Examples
Hands -on 1
Analysis of Binary Data
Tuesday
Assessment of Goodness of fit
Choice of weights
Target mediated drug disposition
Assessment of Godness of FitTarget
Properties of Parameter Estimates
Hands-on 2
Wednesday
Pharmacodynamic Issues
Introduction to Pharmacodynamic Models
Hands-on 3
Introduction to Time delay
Thursday
Design of Experiments and Comparisons of Models
Experimental Design Issues
Comparing Models
Combining Several Sources of Data
Hands-on 4
Instructions for downloading a temporary install of WinNonlin on your lap top will be sent out to all course delegates a few weeks before the start of the workshop! There is no possibility to download the software on site.
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Morning sessions consist of lectures dealing with choice of weights, goodness-of-fit, interpretation of computer output, experimental design and discrimination between rival models. Afternoon sessions are devoted to applying the methods discussed in the lectures to actual data, using Phoenix WinNonlin 6. One afternoon session will be given as an introduction for participants with no, or very little, experience with WinNonlin. The participants work on their own laptops during the hands-on sessions.
IMPORTANT INFORMATION
Delegates MUST bring their own laptops to the course. Instructions on downloading WinNonlin will be provided in advance of the course.
Laptop standards: 2K/XP, 256 mb/RAM, PIII800, 20 Gb, free capacity on HD minimum 2Gb. Participants who do not have the Phoenix WinNonlin 6 program will have an opportunity to download a demo version.
An extensive number of pharmacokinetic and pharmacodynamic models and data sets will be covered and users of software other than WinNonlin will also benefit from the methods discussed. Two days are devoted to the analysis and interpretation of pharmacodynamic data such as steady-state data, indirect response models, link models, tolerance and rebound models, bi-phasic response data, physiological PK/ PD modelling etc. Participants are encouraged to bring their own kinetic/dynamic data.
The textbook on “Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications”, 4th edition (Swedish Pharmaceutical Press 2006), by Dr Gabrielsson and Dr Weiner, will be used throughout the course. In addition, participants will receive a course binder with copies of all presented slides.
NEW BOOK IN OUR WEB SHOP!
Quantitative Pharmacolog
This textbook introduces the basics of PK and PD concepts• outlines the implications of integrating PK and PD analysis• introduces the principles behind different biomarkers and inter-species scaling• discusses experimental design of PK, PD and safety studies in non-human species• covers numerous real life Case Studies from the drug discovery arena.
Cklick on the book to read more
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Quantitative Pharmacology
An Introduction to Integrative
Pharmacokinetic-Pharmacodynamic Analysis.
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Pharmacokinetic and
Pharmacodynamic Data Analysis:
Concepts & Applications 4th edition.
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| Lecturers |
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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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Daniel Weiner is a Sr. Vice President and CTO at Pharsight Corporation. He is a co-developer of PCNonlin, NONLIN84 and WinNonlin and has presented numerous workshops on the statistical evaluation of pharmacokinetic and bioavailability data.
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| Time and Location |
October 20-24, 2013, at Hotel Universo, Rome, Italy. For more information about the hotel, read here. The workshop starts on Monday, October 21 and closes on Thursday, October 24, 2013.
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| Application, confirmation etc |
Early Registration
Early registration is advisable to reserve a place as the number of participants is limited. Those who register before June 1, 2013 and settle the fee before due date on the invoice, will be entitled to claim a complimentary copy of the textbook »Pharmacokinetic and Pharmacodynamic Data Analysis: Concept and Application«, 4th edition, 2006, by Dr.Gabrielsson and Dr. Weiner. The textbook will be handed out on site.
Registration and Confirmation
Delegates will be registered upon receipt of the completed form and a first confirmation will be e-mailed. Detailed information will be sent out closer to the event. The invoice will be sent separately. Payment must be settled before start .
Cancellation
Cancellations should be addressed, in writing to Annica Flodin at the Swedish Academy of Pharmaceutical Sciences. Cancellation of room and workshop may be made free of charge until August 25, 2013. After this date no refunds will be made. Substitutions may however be made at any time. Kindly forward the name of the substitute to Annica.Flodin@Lakemedelsakademin.se
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