Universität Wien
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322571 VU Technological and Biopharmaceutical Aspects of Biologics - M7/M14 (2021S)

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

Details

Language: English

Lecturers

Classes

The course will run for eight sessions every Wednesday morning (09:45-11:15) starting from 14.04.2021 until 02.06.2021.

The course is open to students on the Pharmacy courses:
32.02 Diplom Pharmazie (449 [2] - Version 2011)
32.03 Master Pharmazie (605)
32.04 Master Drug Discovery and Development (606)

The number of participants is limited. Personal registration at the Pharmaceutical Technology and Biopharmacy Secretariat (2G306, UZA2, sonja.holzmann@univie.ac.at) is required by March 15, 2021 at the latest.


Information

Aims, contents and method of the course

This course will be taught using a mixture of online 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 (25% of total mark)
Pharmacokinetics calculation exercise (25% of total mark)
Biosimilars essay (50% of total mark) – terminal assessment.

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

A400, MA8, MA23

Last modified: Th 25.03.2021 11:49