Reproductive Toxicology and Epidemiology

Uitgebreide vaknaam	Reproductive Toxicology and Epidemiology
Leerdoelen	1) The students can explain the mechanisms of drug-induced reproductive toxicology. 2) The students can appraise the preclinical and clinical studies on reproductive toxicology for human teratogenicity. 3) The students can evaluate publications on drug-induced reproductive toxicology, both from epidemiological literature as from toxicological literature and translate and integrate the content to a potential risk for public health. 4) The students can evaluate and discuss the use of experimental animals and alternative testing methods to predict reproductive toxicity. 5) The students can present and discuss the preclinical and clinical studies in a presentation and a written essay.
Omschrijving	Drug-induced reproductive toxicity is a major concern during drug development. Prediction of adverse birth outcome related to drug exposure is mainly based on animal experiments including studies of pharmacokinetics, mechanisms of toxicity, pathogenesis and outcome following exposure to the drug under development. In addition to animal experiments, predictive in vitro tests are increasingly developed. Subsequently clinical and post-marketing studies are performed and represent important tools in safety assessment. Students will acquire knowledge on recent developments in these topics. In addition to basic knowledge in reproductive toxicology, both clinical epidemiological research as well as preclinical experimental research will be presented and discussed. Subsequently the students will apply the acquired knowledge by performing a literature study on selected drugs with known or suspected risk for reproductive toxicity and evaluate the clinical safety and the predictive value of the outcome of the preclinical studies for human safety. The students will present and discuss their findings in the group in a presentation, and an essay will be written. Students are expected to show a critical attitude to evaluate publications and to participate actively in the discussions.
Uren per week
Onderwijsvorm	Hoorcollege (LC), Practisch werk (PRC), Werkcollege (T)
Toetsvorm	Presentatie (P), Schriftelijk tentamen (WE), Verslag (R) (Written examination (40%), written report (40%), oral presentation (20%). Each of these three parts has to be graded minimally with a 5. The total average (40-40-20) of all the parts has to be at least a 5.5 (NB an average of 5.5 will be valued with a 6)))
Vaksoort	master
Coördinator	dr. C.C.M. Schuiling-Veninga
Docent(en)	dr. A.P. Nagelkerke ,dr. C.C.M. Schuiling-Veninga
Verplichte literatuur	Titel Auteur ISBN Prijs Slides presented at the lectures Casarett & Doull's, Toxicology, the basic science of poisons, ed 7, chapter 10, publisher McGraw-Hill C.D. Klaassen Research papers (dependent on the drug selected for the written report and presentation)
Entreevoorwaarden	The course unit assumes prior knowledge acquired from courses equivalent to the bachelor courses Drug Metabolism & Toxicology, and Pharmaco-epidemiology.
Opmerkingen	Minimum of 10 students
Opgenomen in	Opleiding Jaar Periode Type MSc Courses for Exchange Students: Pharmacy - semester I b MSc Farmacie  (Keuzevakken) - semester I b keuze MSc Medical Pharmaceutical Sciences: Drug Toxicology & Translational Technology  ( Master Courses) - semester I b keuze MSc Medical Pharmaceutical Sciences: Pharmaceutical Design and Engineering  (Other possible Electives) - semester I b keuze MSc Medical Pharmaceutical Sciences: Pharmacoepidemiology & Pharmacoeconomics  ( Master Courses) - semester I b keuze MSc Medical Pharmaceutical Sciences: Research  (Electives) - semester I b keuze MSc Medical Pharmaceutical Sciences: Science, Business and Policy  (Electives (5 ECTS)) - semester I b keuze