FDBAa_FAF Biopharmaceutical Aspects of Pharmaceuticals Evaluation

Faculty of Pharmacy
Autumn 2025
Extent and Intensity
2/0/0. 5 credit(s). Type of Completion: zk (examination).
In-person direct teaching
Teacher(s)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (lecturer)
Guaranteed by
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Faculty of Pharmacy
Supplier department: Department of Pharmaceutical Technology – Departments – 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
Literature
    recommended literature
  • Advanced and modern approaches for drug delivery. Edited by Amit Kumar Nayak - Md Saquib Hasnain - Bibek Laha - Sabayasachi Maiti. London: Academic Press, an imprint of Elsevier, 2023, 1 online. ISBN 9780323972192. URL info
  • HILL, Ray G. and Duncan B. RICHARDS. Drug discovery and development : technology in transition. 3rd edition. [Edinburgh?]: Elsevier, 2022, ix, 373. ISBN 9780702078040. info
  • BLASS, Benjamin E. Basic principles of drug discovery and development. Second edition. London: Academic Press, 2021, xvii, 718. ISBN 9780128172148. info
  • Basic pharmacokinetics and pharmacodynamics : an integrated textbook and computer simulations. Edited by Sara Rosenbaum. Second edition. New Jersey: Wiley, 2017, 1 online. ISBN 9781119143185. URL info
  • KENAKIN, Terrence P. Pharmacology in drug discovery and development : understanding drug response. Second edition. Amsterdam: Elsevier, 2017, 1 online. ISBN 9780128037539. URL info
  • Martin's physical pharmacy and pharmaceutical sciences : physical chemical and biopharmaceutical principles in the pharmaceutical sciences. Edited by Patrick J. Sinko - Yashveer Singh. Sixth edition. Philadelphia: Wolters Kluwer, 2011, viii, 659. ISBN 9781609134020. info
Teaching methods
consultation with the teacher
Assessment methods
Oral examination
Language of instruction
English
The course is also listed under the following terms Spring 2025, Spring 2026.
  • Enrolment Statistics (Autumn 2025, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2025/FDBAa_FAF