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Laboratory Test Request Details

Test Request


Request: 05-0862

Status: Closed


Description:

Biotechnology / biopharmaceuticals company needs Preclinical and toxicology studies rG-CSF
Pharmacodynamics studies:
1) in vitro receptor binding assays (comparative to reference product)
2) in vivo rodent models (neutropenic and non-neutropenic), compare test and reference product

Toxicology
28-day repeat dose tox with local tolerance
(repeated dose tox, toxicokinetics, and local tolerance.)

rEpo

Pharmacodynamics studies:
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)

Toxicology
3-month repeat dose tox with local tolerance in appropriate species (e.g. rat or dog)


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