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a dataset collected by the EU Commission in June-September 2018
. Some of these links will therefore die out with time.
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Owner/Developer: Safety Sciences for Medicines (safe sci med)
10 July 2017
During embryo-fetal development xenobiotic substances can interfere with the “normal” development of the organism, while the effects and severity are
dependent on the timing and developmental stage during which the exposure takes place. In contrast to other types of toxicity, interpretation of
reproductive toxicity studies is more complicated and, due to the inclusion of a broad range of endpoints, requires a profound knowledge in order to detect
any effects a new compound can have on mammalian reproduction. Additionally, it is essential to investigate and interpret these results in relation to all other
pharmacological and toxicological data available. The reproductive toxicity of drugs is usually assessed with animal experiments, using the classical three
“segment testing protocols”. The course will also present newer alternative methods in reproductive toxicity testing such as the “whole-embryo-culture” or
the embryonic stem cell test. An additional part of the lectures will discuss the authority guidelines.
Key Subjects Covered by the Course
- Morphology and physiology of the male and female reproductive tract
- Prenatal and postnatal development of mammalian organisms
- Standard testing for fertility impairment and developmental toxicity
- Developmental neurotoxicity/immunotoxicity
- Reproductive toxicity of selected drugs and workplace chemicals
- Relevance of maternal toxicity
- Pharmacokinetic issues in reproductive toxicology
- Endocrine disrupting chemicals
- Toxicogenomics in developmental toxicology
- Guidelines (ICH, OECD etc)
Workshops, Hands-on training, Lecture
Optional / Voluntary
MSc degree in a Life Science discipline or equivalent
Students, Researchers, Regulators and policy-makers, Teachers and educators, Technicians, Scientific officers / Project managers
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), SMEs
Continuing Professional Development, University (Master)
Refinement, Reduction, Replacement
In vitro methods
Partial coverage (e.g. a module)
No species is addressed specifically, Rodents
|Course level on animal species:||
Institute for Laboratory Animal Research (ILAR), Test guidelines (OECD, ISO, etc.)
On successful completion of the module, participants will understand basic reproduction-related pathological findings in a broader context, which will assist
them in communicating with specialist pathologists. More specifically, participants will be able to
- have an appreciation of basic organ functions and their diverse response to toxicity
- know and understand the themes and major processes in organ/system toxicity
- relate the basics of molecular and physiological response of an organ/system to toxicant insult
- be aware of and be able to apply new technologies and methods available for evaluation of organ/system toxicology
-design experiments in order to assess and identify specific organ/system toxicity
- apply relevant parameters to detect organ/system toxicity in the preclinical and clinical setting with statistical methods for risk assessments
|Accreditation body and/or authority that approved the education or training:||
3 ECTS credits
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