FAMH1_13 Methods of Evaluation and Formulation Dossiers of Medicinal Products

Faculty of Pharmacy
Spring 2025
Extent and Intensity
1/1/0. 3 credit(s). Type of Completion: zk (examination).
In-person direct teaching
Teacher(s)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (lecturer)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (seminar tutor)
Guaranteed by
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Department of Pharmaceutical Technology – Departments – Faculty of Pharmacy
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.

The capacity limit for the course is 12 student(s).
Current registration and enrolment status: enrolled: 0/12, only registered: 0/12
fields of study / plans the course is directly associated with
Course objectives
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.
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
    required literature
  • Vetchý D. a kol. Stabilitní studie, bioekvivalenční studie, proces registrace a právní ochrana léčivých přípravků, VŠ skripta. VFU Brno, 2008. info
  • Vetchý D., Vetchý V. Klíč pro statistické vyhodnocování farmaceutických studií, VŠ skripta. VFU Brno, 2006. info
Teaching methods
lectures, seminars
Assessment methods
credit, oral exam
Language of instruction
English
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
Teacher's information
Lectures recommended due to lack of appropriate literature. Seminars (excursions) and successfully written credit test are required.
The course is also listed under the following terms Spring 2020.
  • Enrolment Statistics (Spring 2025, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2025/FAMH1_13