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21st Intermediate Workshop on PK/PD Data Analysis: A four-day Course Using WinNonlin

This intermediate level workshop provides an interface between the numerical analysis of PK and PD data and physiological concepts. Based on the background and concepts provided by the course lecturers, participants will apply this information to the appropriate modelling package (WinNonlin) in hands-on exercises.

The workshop is co-sponsored by EUFEPS

 

"Very useful and interesting"
Participant, Intermediate Workshop on PK/PD Data Analysis: A four-day Course Using WinNonlin

File:Colosseum in Rome-April 2007-1- copie 2B.jpg

TO REGISTRATION

Courses
Date Venue Participation fee (Euro excl. VAT, early/late)
Meals & Accommodation

Accommodation four nights (Sunday October 19- Thursday October 23, 2014) breakfasts, lunches, coffee breaks and one dinner are included in the participation fee.
 

Project Administrator Jenny Hagberg
Jenny.Hagberg@Lakemedelsakademin.se
Who should attend? 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.

 
Delegate fee

Euro 3400, before June 1, 2014. From this date the fee is Euro 4200. (All prices are VAT exclusive and VAT 25% will be added).


 

Programme

Monday
Introduction
Introduction and overview
Introduction to nonlinear regression
Introduction to WinNonlin
Introduction to Hands-on Examples
Hands -on 1
Pattern recognition of PK data
Analysis of Binary Data

Tuesday
Assessment of Goodness of fit

Choice of weights 
Target mediated drug disposition
Properties of Parameter Estimates
Assessment of Godness of Fit
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.

 

Course outline

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.
 

BOOKS IN OUR WEB SHOP! 

Cklick on the books to read more


Quantitative Pharmacology
An Introduction to Integrative
Pharmacokinetic-Pharmacodynamic Analysis.


Pharmacokinetic and
Pharmacodynamic Data Analysis:
Concepts & Applications 4th edition.

Lecturers

 

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.

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.

 

 

Time and Location

October 20-23, 2014, at Hotel Universo, Rome, Italy. For more information about the hotel, read here. The workshop starts on Monday, October 20 and closes on Thursday, October 23, 2014.

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, 2014 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 .

For information about the cancellation policy, cancellation Insurance and VAT, please follow the link here 
 




Läkemedelsakademin. Besöksadress: Wallingatan 26 A. Postadress: Box 1136, 111 81 Stockholm.
Tel: 08-723 50 00. Fax: 08-20 55 11. E-post: info@lakemedelsakademin.se