| Responsible Department | Department of Veterinary Disease Biology | ||||||||||||||
| Earliest Possible Year | Post experience Master´s Programme | ||||||||||||||
| Duration | Outside schedule | ||||||||||||||
| Credits | 6 (ECTS) | ||||||||||||||
| Level of Course | Post experience masters programme Master of Laboratory Animal Science - Module 4 - Elective courses | ||||||||||||||
| Examination | Final Examination oral examination No aid allowed Description of Examination: Oral examination based on submitted poster pass/fail, internal examiner | ||||||||||||||
| Organisation of Teaching | June/August when running | ||||||||||||||
| Language of Instruction | English | ||||||||||||||
| Restrictions | 25 | ||||||||||||||
| Course Content | |||||||||||||||
| Experimental research in animals is justified due to its expected predictability for conditions in other species. Within the same species and even within the same strain or substrain of a species the variation can be large. This phenotypic variation is not only ruled by the genotype but also by environmental factors as simple as housing conditions, feeding and microbiological status. Integration of study results obtained by animal experimentation is generally accepted as valid. However, in studies contradictory results may be obtained, and sometimes great difficulties have been experienced in reproducing experiments of other investigators. The uncertainty in animal characteristics and testing conditions so far have not hindered the insight into biological regulatory mechanisms. However, if animal studies should have the highest degree of predictability and reproducibility, only animals of well-defined health status, housed under well-defined conditions should be used. In vivo drug testing should be planned in order to eliminate the variation caused by improper standardization from group to group or over time and the bias caused by erroneous techniques. This course will highlight the various factors which are critical for variation, and thereby for the reproducibility and predictability in experimental research in animals. The factors are many and some are more important than others. The importance may vary with the goal and design of the study. It is the responsibility of the scientists to take these factors into consideration in order to obtain data which present minimal biological variation and are reproducible. Taking this responsibility seriously will not only improve drug testing, but it will also be in accordance with the ethical obligation to gain as much information as possible whenever using animals for experiments. To enable the student in designing proper in vivo pharmacological studies integrating the following topics: - Efficacy and potency of drugs including dose-response analysis and calculation of ED50. - Strengths and weaknesses in the use of disease models in experimental animals as basis for development of new drugs. - Screening methods. - Confirmatory methods. - Relation between in vitro and in vivo pharmacology. - Tachyphylaxis including comparative studies after acute and chronic administration. - Safety pharmacology methods. - Toxicological methods. - Pharmacokinetic methods. - Methods for quality control (batch-control) of marketed. - Animal related factors. - Handling. - Genetics. - Sex related differences. - Age related changes. - Stress. - Environmental factors. - Microbiological factors. - Housing conditions. - Dietary factors. - Biological rhythms. - Experimental factors. - Factors related to the route of administration of test compound: Intravenous administration, Intraaterial administration, Intramuscular administration, Subcutaneous administration, Intraperitoneal administration. Oral administration. - Factors related to the chemical or physical form of the tests compound. - Feeding factors. - Anaesthesia. - Experimental design: Type I error, type II error, resource equation method, stratification and randomisation. | |||||||||||||||
| Teaching and learning Methods | |||||||||||||||
| Mixture of lectures, theoretical exercises, poster preparation, presentation and discussion. | |||||||||||||||
| Learning Outcome | |||||||||||||||
| Knowledge The student knows in vivo pharmacological methodology including screening methods, disease models (including genetically modified animals), confirmatory methods, relations between in vitro and in vivo pharmacology, safety pharmacology, quality control and toxicological methods. The student also knows about biological, environmental and experimental factors that can influence the experimental outcome. Skills The student can discuss data obtained in animal experiments using correct terminology and point to relevant pitfalls. Competencies The student can design animal experiments using appropriate blinding, controls and randomization. | |||||||||||||||
| Course Literature | |||||||||||||||
| Svendsen, O. and Kornerup Hansen, A.: Biological variation, reproducibility and predictability of in vivo drug testing. Scand. J.Lab.Anim.Sci.25, 86-98, 1998. Textbook is provided. | |||||||||||||||
| Course Coordinator | |||||||||||||||
| Jens Lykkesfeldt, jopl@life.ku.dk, Department of Veterinary Disease Biology/Section for Biomedicine, Phone: 353-33163 | |||||||||||||||
| Course Fee | |||||||||||||||
| DKK 12,000 (includes course materials and course fee). PhD students enrolled in the In vivo Pharmacology PhD programme: Free; Other PhD students: DKK 2,000 (course materials) | |||||||||||||||
| Study Board | |||||||||||||||
| Study Committee V | |||||||||||||||
| Work Load | |||||||||||||||
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