FDMHa_FAF Methods of Evaluation and Formulation Dossiers of Pharmaceuticals

Farmaceutická fakulta
podzim 2025
Rozsah
2/0/0. 5 kr. Ukončení: zk.
Vyučováno kontaktně
Vyučující
prof. PharmDr. Mgr. David Vetchý, Ph.D. (přednášející)
Garance
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Farmaceutická fakulta
Dodavatelské pracoviště: Ústav farmaceutické technologie – Ústavy – Farmaceutická fakulta
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Expanding the knowledge of the student focusing on stability studies, bioequivalence studies, patent protection, registration procedure of the drugs and proper statistic method, 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.
Výstupy z učení
After completing the course, the student will be able to:
- describe the procedures for creating and conducting stability studies;
- describe the factors that influence the bioequivalence of medicinal products;
- identify and describe the procedures leading to the marketing authorization of a medicinal product and the placing on the market of a food supplement;
- apply the principles of legal protection of medicinal products;
- apply appropriate statistical methods to their pharmaceutical studies and experiments
Osnova
  • Original drug development process, generic drug development process
  • Stability studies I. Basic definitions of terms, the purpose of stability studies, good manufacturing practice in relation to the stability studies, the basic procedures for stability testing, stability studies of management practices
  • Stability studies II. Types of stability studies, pharmaceutical packaging in relation to stability, statistical analysis of data from stability studies, documentation, trends in stability studies
  • Bioequivalence studies I. Basic definitions of terms, types of bioequivalence studies
  • Bioequivalence studies II. Biopharmaceutics classification system, the implementation rules of bioequivalence studies in EU
  • Marketing authorisation of medicinal products. Introduction, marketing authorisation applications, marketing authorisation procedures, variations applications, marketing authorisation transfer, parallel import of medicinal products. The content and layout of a complete dossier for a medicinal product, labelling, packaging leaflet data, content and layout of the summary of product characteristics
  • Placing on the market within the EU of food supplements, novel foods or novel food ingredients
  • Legal protection of medicinal products. Industrial Property Office, patent and its protection, utility model and its protection, industrial design and its protection, trademark and its protection.
  • International patent classification, the procedure for searching information in internet databases
Literatura
    doporučená literatura
  • Vetchý D., Vetchý V. Klíč pro statistické vyhodnocování farmaceutických studií, VŠ skripta. info
  • Vetchý D. a kol. Stabilitní studie, bioekvivalenční studie, proces registrace a právní ochrana léčivých přípravků, VŠ skripta. info
  • Modern aspects of pharmaceutical quality assurance : developing & proposing application models, SOPs, practical audit systems for pharma industry. Edited by Minal Ghante - Manohar Potdar - Vidhya Bhusari. Singapore: Springer, 2024, 1 online. ISBN 9789819992713. URL info
Výukové metody
consultations, individual work and self-study
Metody hodnocení
oral exam
Vyučovací jazyk
Angličtina
Předmět je zařazen také v obdobích jaro 2025, jaro 2026.
  • Statistika zápisu (nejnovější)
  • Permalink: https://is.muni.cz/predmet/pharm/podzim2025/FDMHa_FAF