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                            The 17th Intermediate Workshop on
                            Pharmacodynamic Data Analysis:
                            A Hands-on Course Using WinNonlin
                            September 26-30, 2010, Rome, Italy


                                SWEDISH ACADEMY OF
                              PHARMACEUTICAL SCIENCES
Who Should Attend?
The workshop is intended for individuals engaged in the          The textbook on »Pharmacokinetic
pharmaceutical industry, regulatory agencies, contract           and Pharmacodynamic Data
research companies and universities, and for others who          Analysis: Concepts and
want to learn the aspects of model fitting. Previous par-        Applications«, 4th edition (Swedish
ticipants have been toxicologists, kineticists, bioanalyti-      Pharmaceutical Press 2006), by Dr
cal chemists, pharmacologists, clinical pharmacologists,         Gabrielsson and Dr Weiner, will be
anaesthesiologists, clinical research assistants, statisti-      used as course literature through-
cians and scientists from academia and regulatory agen-          out the course. In addition, partici-
cies. Participants should have a background in pharma-           pants will receive a course binder
cokinetics but those with limited experience would also          with copies of all presented slides.
benefit. The number of participants is limited.

What Will You Learn?                                             Dr Johan Gabrielsson is a Sr.
This intermediate level workshop provides an interface           Principal Scientist in the PK/PD
between the numerical analysis of PK and PD data and             section of Discovery DMPK&BAC
physiological concepts. Based on the background and              at AstraZeneca R&D Mölndal,
concepts provided by the course lecturers, participants will     Sweden. He has conducted
apply this information to the appropriate modelling pack-        numerous workshops (3000
age (WinNonlin) in hands-on exercises.                           participants) on biological (PK/
                                                                 PD) data analysis, for example
                                                                 the popular intermediate and
Course Outline                                                   advanced workshops on PK/PD
Morning session consist of lectures dealing with choice          data analysis. Dr Gabrielsson is academically affili-
of weights, goodness-of-fit, interpretation of computer          ated with the department of pharmacology at the
output, experimental design and discrimination between           University of Gothenburg and is the author of the
rival models. Afternoon sessions are devoted to applying         textbook »Pharmacokinetic and Pharmacodynamic
the methods discussed in the lectures to actual data, using      Data Analysis: Concepts and Applications«, 4th ed.
WinNonlin. One afternoon session will be given as an             (2006).
introduction for participants with no, or very little, experi-
ence with WinNonlin. The participants work on their own          Dr Daniel Weiner is a Sr. Vice
laptops during the hands-on sessions.                            President at Pharsight Corporation.
                                                                 He is a co-developer of PCNonlin,
An extensive number of pharmacokinetic and pharma-               NONLIN84 and WinNonlin and has
codynamic models and data sets will be covered and               presented numerous workshops
users of software other than WinNonlin will also benefit         on the statstical evaluation of
from the methods discussed. Two days are devoted to              pharmacokinetic and bioavailability
the analysis and interpretation of pharmacodynamic data          data. He is a co-author, along with
such as steady-state data, indirect response models, link        Dr. Gabrielsson, of the book »Pharmacokinetic and
models, tolerance and rebound models, bi-phasic response         Pharmacodynamic Data Analysis: Concepts and
data, physiological PK/PD modelling etc. Participants are        Applications«.
encouraged to bring their own kinetic/dynamic data.

       Registration can be made on www.lakemedelsakademin.se/17th
Programme                                               General Information
The workshop starts with registration on Sunday, Sept
26 and closes at 15 pm on Thursday, Sept 30, 2010.      Time and Location
                                                        The course will take place on September 26-30, 2010.

September 27: Introduction                              Early Registration
m	Introduction and overwiew                             Early registration is advisable as the number of
m	Linear versus non-linear regression                   participants is limited. Those who register before
m	Review of non-linear regression models                June 30 and settle the fee before due date on
m	Introduction to WinNonlin                             the invoice will be entitled to claim a complimen-
m	Single and multi-exponential models                   tary copy of the textbook »Pharmacokinetic and
m	Fitting multiple dose data                            Pharmacodynamic Data Analysis: Concept and
m	Non-linear kinetic models                             Application«, 4th edition, 2006, by Dr. Gabrielsson
                                                        and Dr. Weiner.
                                                        The textbook will be handed out on site.
September 28: Assessment of
Goodness-of-Fit                                         Registration and Confirmation
m	Choice of weights                                     Participants will be registered upon receipt of the
m	Properties of parameter estimates                     completed form and a first confirmation will be sent
m	Assessment of Goodness-of-Fit                         via e-mail. Detailed information will be sent out closer
m	Correlation of observed and predicted   values        to the course. The invoice will be sent separately.
m	IV Bolus examples                                     Payment must be settled before the start of the
m	Multiple subjects                                     course.
m	Plasma + urine data
                                                        Cancellations should be addressed in writing to Annica
September 29: Pharmacodynamic Issues                    Flodin at the Swedish Academy of Pharmaceutical
m	Steady-state dynamics                                 Sciences (Annica.Flodin@Lakemedelsakademin.se).
m	Effects compartment models
m	Incomplete concentration-response   data              Cancellation of room and course will be subject to
m	Effect-compartment models                             a cancellation fee. 10% of the fee until June 30 and
m	Indirect response models                              40% of the fee between July 1 and August 30.
                                                        After this date no refunds will be made.
                                                        Substitutions may however be made at any time.
September 30: Design of Experiments &                   Kindly forward the name of the substitute to
Comparisons of Models                                   Annica.Flodin@Lakemedelsakademin.se.
m	Theoretical versus practical concerns
m	VIF (PK and PD data)                                  Participation Fee
m	Partial derivatives                                   Euro 3200, Swedish VAT of 25% is not included.
m	Difference functions                                  Non EU-countries and EU countries with a VAT
m	F-test                                                registration number are not subject to VAT.
m	Akaike and Schwartz                                   If applicable, please state your VAT registration
m	Combining several sources of data                     number on the registration form.
m	Combining results from several subjects
m	Multiple infusion data – data reduction               The participation fee is Euro 3800 for applications
m	Model discrimination of response data                 received after June 30, 2010.

                                                        Meals and Accommodation
Instructions for downloading a temporary install        Accommodation four nights, breakfasts, lunches,
of WinNonlin on your lap top will be sent out to all    coffee breaks and one course dinner on Monday night
course delegates a few weeks before start of the        are included in the participation fee. A number of hotel
workshop! There is no possibility to download the       rooms have been booked at Hotel Universo Sunday
software on site.                                       September 26 – Thursday, September 30, 2010.

                                                        Further Information
                                                        For questions or further information, please contact
                                                        project administrator Annica Flodin, by email: Annica.
                                                        Flodin@lakemedelsakademin.se or phone: +46(8)-
                                                        723 50 40.

        Registration can be made on www.lakemedelsakademin.se/17th
Registration Form
The 17th Intermediate Workshop on
Pharmacokinetic/Pharmacodynamic Data Analysis:
A Hands-on Course Using WinNonlin

First name*
Family name*
Postal adress

Participation Fee
Euro 3200, the VAT of 25% is not included. Non EU-countries and EU-countries with a VAT regist-
ration number are NOT subject to the VAT. IF applicable, please state your VAT registration number

Late participation fee Euro 3800 (Payable on applications received after June 30, 2010).

Computers and Early Registration Bonus
  I will bring my own laptop for hands-on exercises during the workshop Standards: 2K/XP, 256 mb/
  RAM, PIII800, 20 Gb, free capacity on HD minimum 2Gb. Participants who do not have the
  WinNonlin program will have an opportunity to download a demo version.
  I am registering before June 30, 2010 and claim the complimentary textbook.

Current position held and brief job description:

Previous experience relevant to the workshop:
Any other information (eg food restrictions):

Completed registration form should be sent to: The Swedish Academy of Pharmaceutical Sciences,
Attn: Annica Flodin, PO Box 1136, SE-111 81 Stockholm, Sweden, Fax No: +46 8 20 55 11.

         Registration can be made on www.lakemedelsakademin.se/17th

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