FDTMH_FAF Methods of Evaluation and Forming Formulation of Pharmaceutical

Faculty of Pharmacy
Spring 2023
Extent and Intensity
1/1/0. 15 credit(s). Type of Completion: zk (examination).
Teacher(s)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (lecturer)
Guaranteed by
prof. PharmDr. Mgr. David Vetchý, 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
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.
Learning outcomes
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
Syllabus
  • 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)
Literature
    recommended literature
  • 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
Teaching methods
lectures, seminars
Assessment methods
oral exam
Language of instruction
Czech
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
The course is taught each semester.
Teacher's information
Seminars (excursions) are required.
The course is also listed under the following terms Spring 2020, Autumn 2020, Spring 2021, Autumn 2021, Spring 2022, Autumn 2022, Autumn 2023, Spring 2024, Autumn 2024, Spring 2025.
  • Enrolment Statistics (Spring 2023, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2023/FDTMH_FAF