Pharmacokinetic - Pharmacodynamic Data Analysis:
Concepts and Applications
There is a tremendous demand for PK and PKPD trained analysts within
Academia, Industry and Regulatory Agencies. There is also a costly time-lag from
the Industry’s need of this competence and request for new courses, to the final
output of competent scientists. The gap between need and what is provided by
educational institutions is continuously growing. Since there are no formal ac-
ademic training programs on the Master level within Europe in this field, this ad-
vanced Summer School is aimed to bridge some of that gap. It will also serve as an
embryo from which a more module-based Master-program can evolve. The
programme is aimed to give the participant a sense that when he/she is entering
the scientific area, this is knowledge that has immediate bearings on the drug
discovery-development process. The course provides an interface between the
computer analysis of PK and PD data and physiological concepts. Based on the
background and concepts provided by the course lecturers, delegates will apply
this information to the WinNonlin industry standard modelling package. A unique
feature of the course is the access to the computer package to undertake hands-
on exercises on real-life case studies and availability of course tutors to help in
problem solving. The participants will be exposed to a wide range of real life
preclinical and clinical pkpd datasets based on single/multiple subjects. There will
be a half a day preparatory course on how to use WinNonlin prior to the main
course (Sunday 19th
A residential course organised by Dept. of Neuroscience and Physiology, Section of
Pharmacology, Gothenburg University, Gothenburg, in collaboration with Astra-
Zeneca R&D.
COURSE TEAM
Dr Johan Gabrielsson is a Senior
Principal Scientist at AstraZeneca
R&D Mölndal. He has conducted
numerous workshops on biological
(PK/PD) data analysis.
MSc Christine Isaksson is a graduate
student at dept of Pharmacology
at GU, and Dr Anders Hall is a
DMPK team manager and project
leader at AstraZeneca R&D Lund.
OUTLINE PROGRAMME
ß
Basic pharmacodynamic theory
Turnover concept and
modelling
Effect compartment models
Receptor on/off binding models
Pharmacodynamic complexities
Single/multiple dose dynamics
Inter-species scaling of PD data
Tolerance & rebound models
PKPD in discov & development
Antibody/protein/peptide PKPD
Aim
This unique advanced workshop provides an interface between the computer analysis of
PK & PD data and physiological concepts. Based on the background and concepts
provided by the course lecturers, delegates will apply this information to the appropriate
modelling package (WinNonlin) in hands-on exercises on real-life case studies.
Who should attend?
Biochemists, DMPK, pharmacology, clinical pharmacology and toxicology scientists, partici-
pants who attended the earlier introductory workshop, and researchers with a working
knowledge of WinNonlin who want to learn more about the advanced features of the pro-
gramme.
Course outline
Morning sessions consist of advanced lectures dealing with pharmacodynamic theory, inter-
pretation of computer output, practical experimental design, discrimination between rival
models and combining data of different sources. Afternoon/evening sessions are devoted to
applying the methods discussed in the lectures to actual data using WinNonlin. One group
session of going from data to insight and building conceptual modelsis planned.
An extensive number of pharmacodynamic models and real life data sets will be covered.
Users of software other than WinNonlin would also benefit from the methods discussed in the
lectures and hands-on sessions. This includes single and multiple dose dynamics, steady-state
data, receptor on/off models, turnover (indirect response) models, link models, tolerance, re-
bound and synergistic models, bi-phasic response data, physiological kinetic/dynamic
modelling, transduction models, diurnal variations, allometric models for scaling kinetic and
dynamic data-parameters. Participants are strongly encouraged to bring their own kinetic-
dynamic data. There will be a half a day preparatory course on how to use WinNonlin prior to
the main course (Sunday 19th
Course Material
The delegate pack, which is provided at the start of the workshop, includes copies of all
presentation material, group exercises, project exercise, and reference list.
The 4thedition of “Pharmacokinetic/Pharmacodynamic Data Analysis: Concepts and
Applications” (Swedish Pharmaceutical Press 2006, 1250 pages).
Limited number of available seats
The total number of seats are limited to 20. A few seats are also available for participants
outside academia. The latter category will be billed for the bench fee.
Programme for ADVANCED COURSE ON PK/PD MODELING
DAY ONE Monday 20th, 2007
Hands-on 1 (Tutors/Johan)
Inst. equil. models, steady-state, log-linear, sigmoidal
Incomplete datasets
Adair model
Design issues and case studies
Hands-on 2 (Tutors/Johan)
Modeling EEG-data with link models
Modeling QT-data with link models
Design issues and case studies
Wrap-up & Project presentation
(Johan/project presenter)
DAY TWO Tuesday 21st, 2007
Hands-on 3 (Tutors/Johan)
Wrap-up & Sniffer time (Johan/ Tutors)
DAY THREE Wednesday 22nd, 2007
Wrap-up & Project presentation
(Johan/project presenter)
DAY FOUR Thursday 23rd, 2007
DAY FIVE Friday 24th, 2007
Information about project exercise
Wrap-up & end of workshop
