FDTaBF_FAF Biopharmaceutics Aspects of Drug Evaluation

Faculty of Pharmacy
Autumn 2024
Extent and Intensity
1/1/0. 25 credit(s). Type of Completion: zk (examination).
Teacher(s)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (lecturer)
Guaranteed by
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Faculty of Pharmacy
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.
Learning outcomes
- Identify the original and generic drug and summarize the important stages of their development - Define generic substitution and describe the degree of similarity of generic medicinal products based on bioequivalence studies - Explain the effects of generic substitution - Define original biological drug and biosimilars - Explain the development and production of biological medicines - Describe the principle and effects of interchangeability of biological drugs - Describe the differences in production and evaluation between a chemical and a biological product
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
Teaching methods
consultation with the teacher
Assessment methods
Oral examination
Language of instruction
English
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 Autumn 2023, Spring 2025.
  • Enrolment Statistics (Autumn 2024, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2024/FDTaBF_FAF