FDTBF_FAF Biopharmaceutics Aspects of Drug Evaluation

Faculty of Pharmacy
Spring 2021
Extent and Intensity
1/1/0. 25 credit(s). Type of Completion: zk (examination).
Guaranteed by
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Faculty of Pharmacy
Prerequisites (in Czech)
FAKULTA ( FaF )
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.
fields of study / plans the course is directly associated with
Course objectives
- Expanding the knowledge of the student focusing on the biopharmaceutical aspects of the evaluation of chemical and biological pharmaceuticals, obtained mainly from world databases containing knowledge from scientific publications especially of foreign research experts and institutions and increasing the ability of the student to process this knowledge into research texts focusing on the content of the study program.
Syllabus
  • 1. Original and generic drug - Development, Production and Evaluation
    2. Generic substitution - definition, bioequivalence study, degree of similarity of generic products and impact on generic substitution.
    3. Original Biological Medicine and Biosimilar - Development, Production and Evaluation
    4. Interchangeability of biological products - view of FDA and EMA, extrapolation of indications, divergence of preparations, proof of consistency of the manufacturing process, processes of change in the production process, immunogenicity
    5. Differences in production and evaluation between chemical and biological products
Literature
    recommended literature
  • Vetchý D. a kol. Stabilitní studie, bioekvivalenční studie, proces registrace a právní ochrana léčivých přípravků, VŠ skripta. VFU Brno, 2008. info
  • Vetchý D., Vetchý V. Klíč pro statistické vyhodnocování farmaceutických studií, VŠ skripta. VFU Brno, 2006. info
Language of instruction
Czech
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
The course is taught each semester.
Teacher's information
Teaching is by way of consultation.
Current literature will be sent to the student by the guarantor upon request.
The course is also listed under the following terms Spring 2020, Autumn 2020, Autumn 2021, Spring 2022, Autumn 2022, Spring 2023, Autumn 2023, Spring 2024, Autumn 2024, Spring 2025.
  • Enrolment Statistics (Spring 2021, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2021/FDTBF_FAF