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Selection of methodology and species

The following selection criteria are worth considering for safety pharmacology studies  [Pg.9]

It is preferable to use the same species for in vivo tests as those used in dystrophia myotonica protein kinase (DMPK) and toxicology— generally rat and dog (an exception would be when the primary pharmacological target in those species is different from the human form). [Pg.9]

The methods should be well established (i.e., not a test invented internally that has not been subject to external evaluation). [Pg.9]

The method/test should be in common use in research, and not one that is not broadly in current use. [Pg.9]

The method/test should be validated in-house with at least one reference substance with known effect in humans. [Pg.9]


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Species selectivity

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