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322571 VU Technological and Biopharmaceutical Aspects of Biologics - M7/M14 (2021S)
Continuous assessment of course work
Labels
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
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.
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.2019.118505Anselmo, Gokarn & Mitragotri, Non-invasive delivery strategies for biologics. Nature Reviews Drug Discovery (2019) 18:19–40
https://doi.org/10.1038/nrd.2018.183Rugo et al., Demystifying biosimilars: development, regulation and clinical use. Future Oncology (2019) 15
https://doi.org/10.2217/fon-2018-0680
https://doi.org/10.1016/j.ijpharm.2019.118505Anselmo, Gokarn & Mitragotri, Non-invasive delivery strategies for biologics. Nature Reviews Drug Discovery (2019) 18:19–40
https://doi.org/10.1038/nrd.2018.183Rugo 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
- 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