This course aims to to provide students with the knowledge of key principles to be considered while doing animal research, applied to both female and male reproduction, e.g. definition of animal models, species selection, animal model types (induced, spontaneous, negative and orphan), “face, construct & predictive validity”.
Moreover, the course aims to shed light on the history and medical breakthrough discoveries by animal research, with the focus on reproduction.
Another important learning objective is represented by the knowledge of Ethics and Animal Welfare, 3Rs principles and evaluation of applied legal requirements in European and Extra-European countries.
Students will be provided with basic statistical notions: bias, randomization (normal, stratified), sample size calculation (incl. standard deviation, power, direction of the effect, type 1 error, commonly used statistical tests), biological relevant size effect.
Notions of toxicological principles (definition of toxicology and toxic agent, dose-response size, ED50 and LD50) represent an additional learning objective.
Finally, this course aims to to provide students with the knowledge of key principles to be considered in teratogenesis: thalidomide case, definition of teratogenesis (Wilson´s principles), repro-toxicology (incl. ICH guide lines, pregnancy and development-stage-specific processes/animal tests, alternative models).