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636-0554-00L 2 Credits DR , MSC D-BSSE , D-INFK
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Modelling and Simulation in Drug Development

Lecturers & Examiners: Dr. Hans-Michael Kaltenbach
VVZ CR n/a

Last Updated: 2026-06-01 11:30:45

Abstract

This 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.

Objective

The 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.

Content

Understanding 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.

General Information

Language
English
Levels
DR , MSC
Frequency
Yearly recurring

Examination

Type
ungraded semester performance

Registration & Places

Max Places
20

Course Components

Type Title Time & Place Hours
lecture Modelling and Simulation in Drug Development
Block course, 5 full days on 8-12 September. The course is intended for students in the CBB and Biotechnology master programs and for PhD students at BSSE. Students from other departments / programs are welcome to join if space is available; please contact me at if you are interested.
  • 08.09 Date 09:15-17:00 (BSS E 44)
  • 09.09 Date 09:15-17:00 (BSS E 44)
  • 10.09 Date 09:15-17:00 (BSS E 44)
  • 11.09 Date 09:15-17:00 (BSS E 44)
  • 12.09 Date 09:15-17:00 (BSS E 44)
40 h semesterly

Offered In