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Biotechnology / biopharmaceuticals company needs Preclinical and toxicology studies rG-CSF
1) in vitro receptor binding assays (comparative to reference product)
2) in vivo rodent models (neutropenic and non-neutropenic), compare test and reference product
28-day repeat dose tox with local tolerance
(repeated dose tox, toxicokinetics, and local tolerance.)
1) in vitro comparative bioassays (e.g. receptor-binding studies, cell proliferation assays)
2) in vivo: erythrogenic effects of test product and the reference product should be quantitatively compared in an appropriate animal assay (polycythaemic and/or normocythaemic mouse assay)
3-month repeat dose tox with local tolerance in appropriate species (e.g. rat or dog)
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