Mouse studies transgenic

The relevance (and return on investment) for the bioassays preformed in mice have been questioned for some time. In 1997, ICH opened the possibility for the substitution of some form of short- or medium-term mouse test as an alternative for the traditional lifetime mouse bioassay. FDA has subsequently stated that it would accept validated forms of a set of medium-term mouse studies based on transgenic models, and significant effort has since gone into such validation. 

In a Tg.AC transgenic mouse model using similar doses to the first mouse study, there was no treatment-related increase in the incidence of skin tumours after skin application. 

Wilcock DM, Colton CA (2008) Anti-amyloid-beta immunotherapy in Alzheimer s disease relevance of transgenic mouse studies to clinical trials. J Alzheimers Dis 15 555-569 Wilhamson J, LaRusse S (2004) Genetics and genetic counseling recommendations for Alzheimer s disease, frontotemporal dementia, and Creutzfeldt-Jakob disease. Curr Neurol... 

Myhr, B. C. Validation studies with Muta Mouse a transgenic mouse model for detecting mutations in vivo. Environ. Mol. Mutagen. 1991, 7S(4), 308-315. 

In vivo, transgenic mouse studies have mapped the region of PrP important in transmission of TSE infectivity across species barriers to an... 

The caveat with all of the current transgenic mouse models of familial TSE is that none precisely replicate the human disease. Almost all of them are dependent on transgenic mouse studies that involve both overexpression and random insertion of the transgene. In fact, when a single copy of a PrP mutant associated with GSS (proline to leucine at 102) is specifically substituted into the PrP gene locus, no spontaneous neurodegenerative disease is observed (Manson et al, 1999). Rather, an increased resistance to infection with scrapie is found (Manson et al,... 

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