ULLA Summer School 2005
Themes and Courses
Theme 8 - Clinical drug development and in silico modelling - Mats Karlsson
Course 8:1 Introduction to PK/PD
Course leader: R Sandström and M Sandström
Last for
2 days
Level
Basic
Maximum number of students: No limitation
Instructors: Rikard Sandström, Marie Sandström, Ulrika Simonsson
Description: The course covers the absorption, distribution, metabolism and excretion of drugs in the human body. The
connection between pharmacokinetic and biopharmaceutic parameters and how they effect drug absorption. The oral
route for drug absorption will be high lighted. Calculations and interpretations of key parameters that describes events
in pharmacokinetics and pharmacodynamics after single as well as after multiple drug dosing. The course also covers
the connection between drug concentration/time profiles and pharmacological effect, drug dosing strategies, interindividual variability in drug disposition and drug interactions. During the course different methods for measuring, and
different models for describing drug absorption, plasma protein binding, distribution kinetics, hepatic and renal
elimination and the pharmacokinetics of metabolites
Objectives: After the course the students shall have required basic knowledge and understanding in the fields of
pharmacokinetics and pharmacodynamics.
The students shall have the ability to interpret different parameters effect on a drugs absorption, distribution,
elimination and pharmacological effect.
Prerequisite: Basic knowledge in Pharmacology, Physiology and Pharmacy
Course 8:2 Determinants of drug response and variability in early clinical development
Course leader: Oscar Della Pasqua
Last for
2 days
Level
Intermediary
Maximum number of students: 12-16
Instructors: Oscar Della Pasqua
Description: Topics: Issues in Drug Development Strategy, Determinants of Drug Response, Drug-receptor interaction
& In vivo signal transduction, Dose versus concentration, Delivery Rate as determinant of drug response, Linking
pharmacokinetics, pharmacodynamics and disease, Intrinsic & Extrinsic Determinants of Variability in Drug
Response,Time-dependent processes, Disease Progression, Compliance and Drug-drug interaction.
Format: Morning: lectures, Afternoon: case study (hands-on simulation) and group presentation
Objectives: At the end of this training course, participants will:.Learn to identify key issues in clinical drug
development. Understand the determinants of drug response. Identify and understand determinants of variability.
Understand how the interaction between pharmacokinetics, pharmacodynamics and delivery affects therapeutic
response. Know the principles of (population) pharmacokinetic-pharmacodynamic modelling.
Prerequisites: Basic pharmacokinetics, pharmacology, physiology and statistics are required. Previous experience with
PK/PD modelling and simulation is desirable.
Course 8:3 Ethics and conduct in clinical/biomedical research
Course leader: O Della-Pasqua
Last for
1 day
Level
Basic
Maximum number of students: 20
Instructors: Oscar Della-Pasqua
Description: The one day awareness training will cover the following aspects: Introduction to Ethics and Scientific
Conduct in Clinical/Biomedical Research. Good Academic Research Practice (GARP). Peer pressure, conflict of
interests and fraud. Guidelines and standards of quality in biomedical research. Good Clinical Practice (GCP). Medical
ethics (Declaration of Helsinki), conflict of interests and fraud. Guidelines and regulations within the Pharmaceutical
Industry. Publish or perish: ethics and fraud in scientific literature.
Format: Morning: lectures and discussion. Afternoon: case study and group presentation
Objectives: At the end of this awareness session, participants will: Understand the drivers and standards of quality in
clinical/biomedical research. Learn how to assess quality in published scientific literature and study reports. Learn how
to ensure transparency and rigour in clinical/biomedical research. Develop a code of ethics and conduct for themselves
Prerequisites: Biomedical /clinical research experience within a PhD programme.