|
Lecturer(s)
|
-
Široká Jitka, PharmDr. Ph.D.
|
|
Course content
|
Introduction to existing legislation, sources of information (pharmacopoeia, SIDC, FDA, EMA, ICH), classification of drugs Basic terms - drug, the active ingredient, medicine Quality, quality assurance; Good Manufacturing and Laboratory Practice Research and development of pharmaceuticals - the original medicines, generics Methods used in the control of chemical drugs, the determination of the active substance in the dosage form, testing the purity and stability of medcines, drugs identification on the basis of their physical constants. Control of drugs using chemical methods - general reactions, reaction of different structural types of drugs Volumetric determination in drug control Fundamentals of pharmacokinetics and biotransformation of drugs, ADME methods Clinical analysis - processing of biological material, sample preparation, focused on liquid chromatography coupled with mass spectrometry Forensic analysis Doping control and analysis
|
|
Learning activities and teaching methods
|
|
Lecture
|
|
Learning outcomes
|
To inform students about general problems of drugs with detailed focus on pharmaceutical analysis.
Students will gain knowledge in the field of pharmaceutical analysis. They should know the most important legislative requirements and they can work with the pharmacopoeia. Furthermore, they should learn some technical terms and classification of drugs. Students are also introduced to the issue of research and development of potential pharmaceuticals, including ways of their testing. In selected groups of drugs they know the nature of the tests to confirm the identity and purity of pharmaceuticals. They focus on analytical methods used for the determination of the active substance.
|
|
Prerequisites
|
Knowledge of inorganic, organic and analytical chemistry.
|
|
Assessment methods and criteria
|
Oral exam, Written exam
Final test (70% = passing)
|
|
Recommended literature
|
-
Český lékopis. Poslední platné vydání, Grada Praha.
-
Balíková, M. (2017). Forenzní a klinická toxikologie. Galén Praha.
-
Klimeš J. (2007). Kontrola léčiv II. Praha, Karolinum.
-
Klimeš J. (2006). Kontrola léčiv I. Praha, Karolinum.
-
Kuchař M. (2008). Výzkum a vývoj léčiv. VŠCHT.
-
Lüllmann H. (2004). Farmakologie a toxikologie. Grada, Praha.
-
Nová A. (2015). Základy ADME a toxikologického hodnocení léčiv v preklinickém vývoji. UPOL, Olomouc.
|