Department of Natural Sciences
Pharmacology and Toxicology (MSC Bio)
- in MSc Biomedical Sciences, 1st semester
- 6h/week (2L/2E/2P)
- Credits: 8 ECTS
- After successfully completing the module, students are able to work out and understand a new medicinal product (new chemical entity or biological), its dosage form and the relevant clinical picture regarding pharmacokinetic (PK) and pharmacodynamical (PD) properties. This methodology can be directly applied for independently working out further medicinal products relevant in later work life (clinical or biomedical research).
- Lectures on drug actions, pharmacokinetics, (L)ADME, pharmacodynamics (mode of action), adverse effects, pharmaceutical interactions, toxicology, in particular: biotransformation, bioactivation, elimination, medical terminology, pharmacokinetic models, cumulation, bioavailability, prodrug concept, enterohepatic circulation, pharmacogenetics, preclinical and clinical trials/bioequivalence studies/regulations for drug approval.
Exercises; in small groups, students have to work on present and dispute about a new medicinal product on the basis of an EPAR (European Product Assessment Report) and a SmPC (Summary of Product Characteristics).
- The students are able to analyze (incl. data analysis) and answer questions in the context of PK (urine analysis, toxicology, metabolism) and PD (enzyme based assay).
- Several experiments in small groups on pharmakokinetics (plasma samples) including the mathematical analysis (excel), one compartment model; oral input, intravenous dose such as or bolus dose or infusion, bolus multiple dose (cumulation); analysis of urinary data, calculation of the relevant pharmacokinetic parameters.
- Analysis of metabolites (SPE/HPLC or GC/MS of a chosen urine sample) and enzyme based assay (mode of action of a drug).
- Module with mark
- Oral examination (70%)
- lab reports (30%)
- presentation and discussion sessions: active participation required.
- Drug actions - Basic Principles and therapeutic aspects E. Mutschler/H. Derendorf;
- MedPharm Scientific Publishers (ISBN 3-88763-021-1)
- Pharmacokinetic Processes, mathematics and applications
- Peter G. Welling Wiley Science, newest edition
- Applied Biopharmaceutics and Pharmacokinetics L. Shargel/A.Yu; McGraw-Hill Medical Publishing Division; newest edition
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