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Has anyone ever attempted to scale predicted human exposure from a SQ
administered sustained release formulation, from data obtained in
dogs receiving the formulation?
Predicting Human Exposure to Drugs from Sustained Release
Formulations using Dog Data
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David,
I think a good reference to start with is the article below. The
research group had rats and dogs in their scaling scheme of
experiments. The drug was pegylated EPO (a longer acting form of EPO)
given both IV and SQ for the sake of comparison. I am sure you must
have smaller animal data generated somewhere during the development
of your drug.
I hope this helps.
Murad
Jolling K, Perez Ruixo JJ, Hemeryck A, Vermeulen A, Greway T.
Mixed-effects modelling of the interspecies pharmacokinetic scaling of
pegylated human erythropoietin.
Eur J Pharm Sci. 2005 Apr;24(5):465-75.
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