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Comparative nonclinical studies were conducted with the proposed biosimilar PF-05280586 and rituximab-EU (MabThera®). In side-by-side analyses, peptide maps and complement-dependent cytotoxicity assay results were similar. Sexually-mature cynomolgus monkeys were administered PF-05280586 or rituximab-EU as a single dose of 0, 2, 10, or 20 mg/kg on day 1 and(More)
Trastuzumab (Herceptin®) is a humanized monoclonal antibody (mAb) that binds to the HER2 protein. PF-05280014 is being developed as a potential biosimilar to trastuzumab products marketed in the United States (trastuzumab-US) and European Union (trastuzumab-EU). Nonclinical studies were designed to evaluate the similarity of PF-05280014 to trastuzumab-US(More)
Dried blood spot (DBS) sampling has gained considerable interest as a microsampling technique to support drug discovery and development owing to its enormous ethical and practical benefits. Quantitative determinations of drugs and/or their metabolites collected in DBS matrix in its current format, however, have encountered technical challenges and(More)
BACKGROUND Liquid microsampling can realize ethical benefits through reduced animal usage. It inherently deals with a minute amount of sample; for example, <30 µl of plasma, which is generally insufficient for multiple analyses. RESULTS We report accurate weighing and dilution-assisted plasma microsampling (AWADA-PM) that substantially increases sample(More)
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