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Rome, Italy |
3200/3800 EUR(Euro) after 2010-06-30 |
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To registration »
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| Meals & Accommodation |
Accommodation four nights (Sunday September 26 – Thursday September 20, 2010) incl. breakfasts, lunches, coffee breaks and a course dinner on Monday night are included in the participation fee.
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| Project Administrator |
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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 3200, the Swedish VAT of 25% is not included. Non EU-countries and EU countries with a VAT registration number are NOT subject to the VAT. If applicable, please state your VAT registration number on the application form. Late Registration Fee Euro 3800 (Payable on applications received after June 30.)
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The workshop starts at 8.30 am September 27 and closes at 15 pm September 30 2010.
Monday September 27: Introduction
Introduction and overview
Linear versus non-linear regression
Review of nonlinear regression models
Introduction to WinNonlin
Single and multi-exponential models
Fitting multiple dose data
Non-linear kinetic models
Tuesday September 28: Assessment of Goodness-of-fit
Choice of weights
Properties of parameter estimates
Assessment of Goodness-of-Fit
Correlation of observed and predicted values
IV Bolus examples
Multiple subjects
Plasma + urine data
Wednesday September 29: Pharmacodynamic Issues
Steady-state dynamics
Effects compartment models
Incomplete concentration-response data
Effect-Compartment models
Indirect response models
Thursday September 30: Design of Experiments and Comparisons of Models
Theoretical versus practical concerns
VIF (PK and PD data)
Partial derivatives
Difference functions
F-test
Akaike and Schwarz
Combining several sources of data
Combining results from several subjects
Multiple infusion data – data reduction
Model discrimination of response data
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.
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| Lecturers |
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Dr Johan Gabrielsson is a Sr. Principal Scientist in the PK/PD section of Discovery DMPK&BAC at AstraZeneca R&D Mölndal, Sweden. He has conducted numerous workshops (3000 participants)on biological (PK/PD) data analysis, for example the popular intermediate and advanced workshops on PK/PD data analysis. Dr Gabrielsson is academically affiliated with department of pharmacology at University of Gothenburg and is the author of the textbook "Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications", 4th ed. (2006).
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Dr 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 |
The course will take place on September 27-30, 2010 at the Hotel Universo in Rome, Italy. Read more about Hotel Universo here.
The Universo Hotel is one of the few Roman hotels with an almost hundred year tradition.
The hotel is situated in the heart of the capital, not far from the Termini railway station and a few steps away from the Teatro dell'Opera and government buildings such as the Ministry of the Interior, Ministry of Defence (Palazzo Baracchini) and the Ministries of the Treasury and Agriculture in Via XX Settembre.
It is next to the Palazzo Massimo Museum. Piazza Venezia, the Borghese Museum and Via Veneto are a short stroll away, as are the Quirinal Palace, Capitol Hill, the Colosseum and the Roman Forum.
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| Registration, confirmation etc |
Early Registration
Early registration is advisable to reserve a place as the number of participants is limited. Those who register before June 30 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 the start of the course.
Cancellation
Cancellations should be addressed, in writing to Annica Flodin at the Swedish Academy of Pharmaceutical Sciences. Cancellation of room and course may be made for an administrative charge: 10% of the fee until June 30, 40% of the fee between July 1st and August 30. 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
Computers
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.
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