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For AMG 317, a fully human monoclonal antibody to interleukin receptor IL-4Rα, we developed a population pharmacokinetic (PK) model by fitting data from four early phase clinical trials of intravenous and subcutaneous (SC) routes simultaneously, investigated important PK covariates, and explored the relationship between exposure and IgE response. Data for(More)
The design of instrumentation used to measure the bioimpedance of skin or tissue is presented. An inexpensive, component level approach, appropriate for use by researchers rather that commercial applications, is emphasized. The design and implementation process is thoroughly explained and design tradeoffs are discussed with relation to various applications.(More)
The development of biosimilar products is expected to grow rapidly over the next five years as a large number of approved biologics reach patent expiry. The pathway to regulatory approval requires that similarity of the biosimilar to the reference product be demonstrated through physiochemical and structural characterization, as well as within in vivo(More)
The physiological responses to needle stimulation of an acupuncture point and a nearby control point were compared in six healthy participants. The electrocardiogram (ECG), respiration, and electrodermal response (EDR) were measured along with the times of needle insertion, interim needle stimulation and needle removal. In addition to the aforementioned,(More)
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