Universität Wien

322571 VU Technological and Biopharmaceutical Aspects of Biologics - M7/M14 (2023S)

1.00 ECTS (1.00 SWS), SPL 32 - Pharmazie
Continuous assessment of course work

Registration/Deregistration

Note: The time of your registration within the registration period has no effect on the allocation of places (no first come, first served).

Details

Language: English

Lecturers

Classes

The number of participants is limited! Registration from 15. Mai 2023 to 31. Mai 2023 at the latest !!


Information

Aims, contents and method of the course

This course will be taught using a mixture of lectures and tutorials (a total of 7 sessions).

Learning aims:
- Knowledge of formulation principles for biotech products
- Challenges of protein formulations (addressing challenges through preformulation)
- Knowledge of formulation processes and ingredients
- Knowledge of drug delivery mechanisms and kinetics
- Knowledge of parenteral controlled release formulations
- Knowledge of the basic concepts of Pharmacokinetics
- Overview on the pharmacokinetic models
- Knowledge concerning the relevant pharmacokinetic parameters
- Basics of the physiological background of the Pharmacokinetics
- Application of the pharmacokinetic evaluation on selected drugs

Assessment and permitted materials

Shelf life prediction calculation exercise (50% of total mark)
Pharmacokinetics calculation exercise (50% of total mark)

Minimum requirements and assessment criteria

A minimum of total of 50% in each of the assessment exersices will be necessary to pass this course.

Examination topics

Reading list

Wang & Ohtake, Science and art of protein formulation development. International Journal of Pharmaceutics (2019) 568:118505
https://doi.org/10.1016/j.ijpharm.2019.118505

Anselmo, Gokarn & Mitragotri, Non-invasive delivery strategies for biologics. Nature Reviews Drug Discovery (2019) 18:19–40
https://doi.org/10.1038/nrd.2018.183

Rugo et al., Demystifying biosimilars: development, regulation and clinical use. Future Oncology (2019) 15
https://doi.org/10.2217/fon-2018-0680

Association in the course directory

MA8, MA23

Last modified: Fr 08.11.2024 00:19