636-0554-00L  Modelling and Simulation in Drug Development

SemesterHerbstsemester 2023
DozierendeH.‑M. Kaltenbach
Periodizitätjährlich wiederkehrende Veranstaltung

KurzbeschreibungThis course introduces how Modelling and Simulation (=mathematical modelling) is applied today for the development of novel drugs in the pharmaceutical industry. Background lectures are combined with hands-on exercises on real-world examples.
LernzielThe goal of this course is to provide students with a general understanding of drug development and pharmacology and how Modelling and Simulation is used to develop new drugs. Together with the application, the course will provide the background in the statistical methodologies used to model multivariate and time-dependent data with several levels of statistical variability.
InhaltUnderstanding the pharmacology, pharmacokinetics and pharmacodynamics (PK/PD) of novel drugs is key for a successful drug development process. Modelling and Simulation of these data is at the core to gain this understanding. Focusing on the application using real world examples, this course will introduce the statistical methodologies that have been developed to describe complex biological and pharmacological data with several levels of statistical variability.
The course will cover the basics of drug development and pharmacology with a focus on the principles of drug absorption, distribution, metabolism and excretion (ADME) and drug pharmacokinetics and pharmacodynamics (PK/PD). The different drug formats (small molecules, biologics, cell-based therapies, gene therapies and oligonucleotide formats) and their pharmacological properties will be introduced. The translation from animal to human to inform first-in human dose selections will be discussed.
The methodology part will cover compartmental PK/PD modelling, the practical aspects of numerical solutions of ordinary differential equation (ODEs) and the theory on non-linear mixed effects (NLME) modelling, which has become the de-facto standard methodology in the pharmaceutical industry. Practical problems of Modelling and Simulations will be discussed including parameter identifiability, model development and model evaluation and the application (or not) of the Occam’s Razor.
The course will focus on hands-on exercises using contemporary real-world examples from the pharmaceutical industry and provide necessary theoretical and methodological background in accompanying lectures.
The course is organized jointly by D-BSSE and LYO-X, a Quantitative Systems Pharmacology consulting company situated in Basel.
Voraussetzungen / BesonderesBasics of dynamic systems (e.g., BSSE courses by Iber or Kammash, or CSB course by Stelling)
Basics of statistics and R (e.g., BSSE courses by Kuipers or Kaltenbach)