FABU1_15 Biopharmaceuticals

Farmaceutická fakulta
podzim 2021
Rozsah
1/0/0. 2 kr. Ukončení: zk.
Vyučující
doc. PharmDr. Oldřich Farsa, Ph.D. (přednášející)
Garance
doc. PharmDr. Oldřich Farsa, Ph.D.
Ústav chemických léčiv – Ústavy – Farmaceutická fakulta
Rozvrh
každý sudý čtvrtek 8:00–9:40 44-247
Předpoklady
FAKULTA(FaF) || OBOR(MUSFaF)
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Biotherapeutics ("or biological and biotechnological substances" in WHO terms) are medicines with a relative molecular mass in most greater than 1 000 (in contrast to classical "chemical" medicines called "small molecules"). They are usually produced in other ways than by common chemical synthesis (recombinant technologies are typical). They mostly have neither exactly defined chemical structure nor exactly known relative molecular mass because they are often mixtures of structurally related biopolymers. They frequently exhibit primary structure (monomers' sequence, eg. that of amino acids, nucleotides, or monosaccharides) and secondary, tertiary, and quarternary one. This group includes eg. monoclonal antibodies, modified receptor molecules, protein and peptide hormones, cytokines, hematopoietic factors, modified oligonucleotides, vaccines of all generations, and heparins. Biologic therapy grows rapidly during the past decades and is often considered to be the last chance in the treatment of cancer or autoimmune diseases. The wider usage of biotherapeutics is still slowed down by their high price. This problem is, however, being a step wisely overcome by the introduction of biosimilar products which mean an analogy of generics in terms of small molecules.
Výstupy z učení
A student will, after passing the subject, be capable to enumerate main groups of biologic drugs; their main structural characteristics; their general mechanisms of activity; at least 5 examples of drugs in use or development from every structural group.
Osnova
  • Content of the discipline expressed as topics of lectures:
    Biological therapeutics (biologics) and conventional small molecule drugs - definition, history, contemporary situation, classification of biologics, fundamentals of their terminology. (Farsa)
    Modified receptor molecules as therapeutics.(Farsa)
    Drugs with peptide structure (except enzymes and antibodies). (Farsa)
    Antisense oligonucleotides. Poly- and oligosaccharides as drugs. (Farsa)
    Therapeutic monoclonal antibodies. (Farsa)
    Enzymes as drugs. (Farsa)
    Specific methods of analysis of biologics. (Farsa)
Literatura
    doporučená literatura
  • 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.
  • Ministry of Health, Labour and Welfare of Japan. The Japanese Pharmacopoeia. 17th Edition, English version. Tokio, 2016.
  • WHO. World Health Organization: International Nonproprietary Names (INN) for biological and biotechnological substances (a review), WHO/EMP/RHT/TSN/2016.1. Geneva, 2016.
  • WHO Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva, 2013.
  • Ng Rick. Drugs: From Discovery to Approval. Second Edition. 2009. ISBN 978-0-470403587. URL info
Výukové metody
Lectures
Metody hodnocení
A grade. A written quiz.
Vyučovací jazyk
Angličtina
Další komentáře
Studijní materiály
Předmět je dovoleno ukončit i mimo zkouškové období.
Předmět je zařazen také v obdobích jaro 2020, podzim 2020, podzim 2022, podzim 2023, podzim 2024.