Teratogenicity testing

Smithells RW, Sheppard S. Teratogenicity testing in humans a method demonstrating safety of Bendectin. Teratology 1978 17 31-6. 

The Committee had required as a minimum, teratogenicity testing in two species, one of which should preferably be a non-rodent, for one generation only. They also recognised the limitations of teratogenicity tests in animals but emphasised that only in the most exceptional circumstances would they release any drug for clinical trial in women of child-bearing age rmtil the appropriate tests on animals had been carried out satisfactorily. 

Paul C. Barrow (ed.), Teratogenicity Testing Methods and Protocols, Methods in Molecular Biology, vol. 947, DOI 10.1007/978-1 -62703-131 -8 1, Springer Science+Business Media, LLC 2013... 

Since the main intention of the present issue is teratogenicity testing, this chapter will mainly focus on OECD guideline 414 and discuss methodological issues in this context. For a better overview, the remaining Guidelines will be briefly summarized ... 

A single pertinent species is sufficient for the preclinical developmental testing of vaccines (as opposed to a rodent and non-rodent species for the teratogenicity testing of other pharmaceuticals, see Table 1). 

Key words Teratogenicity testing. Cosmetics, Cosmetic ingredients, EU Cosmetic Directive... 

Nevertheless, the rat is not always the appropriate species for the teratogenicity testing of all types of test item its pertinence needs to be justified for each study (see Note 1). 

The Sprague Dawley and Wistar are the most commonly used strains of rat for teratogenicity testing. 

Stuckhardt JL, Poppe SM (1984) Fresh visceral examination of rat and rabbit fetuses used in teratogenicity testing. Teratog Carcinog Mutag 4 181-188... 

Brown NA (1987) Teratogenicity testing in vitro status of validation studies. Arch Toxicol Suppl 11 105-114... 

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