aFAMH1_13 Methods of Evaluation and Formualtion Dossiers of Medicinal Products

Farmaceutická fakulta
jaro 2026

Předmět se v období jaro 2026 nevypisuje.

Rozsah
1/1/0. 14p+14s. 3 kr. Ukončení: zk.
Vyučující
prof. PharmDr. Mgr. David Vetchý, Ph.D. (přednášející)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (cvičící)
Garance
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Ústav farmaceutické technologie – Ústavy – Farmaceutická fakulta
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Methods of evaluation and forming formulation files of the drugs

The subject presents a number of issues from the applied pharmacy - stability studies, bioequivalence studies, patent protection and registration procedure of the drugs. Students can learn the aplication of proper statistic method for their pharmaceutical studies and experiments also.
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
Introductory lecture. The subject content, original drug development process, generic drug development process (lecture 2 hrs)
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 (lecture 2 hrs)
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 (lecture 2 hrs)
Bioequivalence studies I. Basic definitions of terms, types of bioequivalence studies (lecture 2 hrs)
Bioequivalence studies II. Biopharmaceutics classification system, the implementation rules of bioequivalence studies in EU (lecture 2 hrs)
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 (lecture 2 hrs)
Placing on the market within the EU of food supplements, novel foods or novel food ingredients (lecture 2 hrs)
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 (seminar 2 hrs)
Excursions to the pharmaceutical company Oncomed
Excursions to the pharmaceutical company Angelini
Credit test (seminar 2 hrs)
Amending credit test, replacement seminar, credit (seminar 2 hrs)
Literatura
    doporučená literatura
  • Drug delivery : principles and applications. Edited by Binghe Wang - Longqin Hu - Teruna Siahaan. Second edition. Hoboken, New Jersey: Wiley, 2016, 1 online. ISBN 9781118833230. 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
Výukové metody
lectures, seminars
Metody hodnocení
credit, oral exam
Vyučovací jazyk
Angličtina
Informace učitele
Seminars (excursions) and successfully written credit test are required.
  • Permalink: https://is.muni.cz/predmet/pharm/jaro2026/aFAMH1_13