FaF:FDTMH_FAF Methods of Evaluation and Form - Course Information

FDTMH_FAF Methods of Evaluation and Forming Formulation of Pharmaceutical

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

• Pharmaceutical Technology (programme FaF, D-FT) (2)
• Pharmaceutical Technology (programme FaF, D-FTA)

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.

• Enrolment Statistics (Spring 2023, recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2023/FDTMH_FAF