FDCBA_FAF Biofarmaceutics

Faculty of Pharmacy
Spring 2021
Extent and Intensity
1/1/0. 15 credit(s). Type of Completion: zk (examination).
Teacher(s)
doc. PharmDr. Oldřich Farsa, Ph.D. (lecturer)
Guaranteed by
doc. PharmDr. Oldřich Farsa, 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
Biologic therapeutics incerase very rapidly in number in recent decades. Their growth has mainly accelerated since aprovals of biosimilars by the European Medicines Agency (EMA) had started. Not only notoriuosly known therapeutic monoclonal antibodies are in spotlight but also heamotopoietic stimulators, protein and peptide hormones, cytokines and therapeutic enzymes and also polymeric molecules of other than peptide character such as antisense oligonucleotides and olig- or polysaccharides must be taken into account. Vaccines also cannot be passed over although their look is today completely different from initial dead or attenuated patogens. The goal of the advanced course intended for Ph.D. students is not only to present pharmacotherapeutic aspects of these medicines but also to acquaint students with their structure aspects on various levels including semi-synthetic modifications and also with methods of ther analysis and quality assessment.
Learning outcomes
The knowledge of the topics of the discipline to the extent which will be preliminarily agreed among the guarantor, Ph.D. student and his/her tutor.
Syllabus
  • Syllabi of the discipline
    Biologic therapeutics and classical medicines, definitions and terminology. History, up-to-date state, classification of biologic therapeutics, fundamentals of nomenclature, main features of individual groups.
    Originator products and biosimilars.
    Modified receptor molecules as medicines.
    Imunology preaparatios. Classic and modern vaccines.
    Therapeutic peptides and proteins (except enzymes, antibodies and haematopoietic factors).
    Haematopoietic growth factors.
    Antisense oligonucleotides.
    Poly- and oligosaccharides as medicines.
    Therapeutic enzymes.
    Research and development of biologic therapeutics.
    Analysis and quality control of biologic therapeutics.
Literature
    required literature
  • Beneš L. Biofarmaceutika (Bioléčiva) Chem. listy 101, 18 - 24 (2007). URL info
  • WHO. World Health Organization: International Nonproprietary Names (INN) for biological and biotechnological substances (a review), WHO/EMP/RHT/TSN/2016.1. Geneva, 2016. URL info
  • Farsa O. Terapeutické monoklonální protilátky v léčbě a ve vývoji. Praha, 2013. URL info
  • Ng Rick. Drugs: From Discovery to Approval. Second Edition. 2009. ISBN 978-0-470403587. URL info
    not specified
  • Chrastilová Z., Macková M., Král V. Bioléčiva - jaký je jejich skutečný potenciál? Chem. listy 101, 25 - 35 (2007). URL info
  • Ministry of Health, Labour and Welfare of Japan. The Japanese Pharmacopoeia ? 17th Edition, English version. Tokio, 2016. URL info
  • U.S. Department of Health and Human Services Food and Drug Admin. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD, USA, 2015. URL info
  • WHO Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva, 2013. URL info
Teaching methods
Self-study of resources recommended by the teacher.
Assessment methods
With a mark
Oral exam.
Language of instruction
Czech
Further Comments
The course can also be completed outside the examination period.
The course is taught each semester.
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/FDCBA_FAF