Pharmacology
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Naïve, protein-naïve and non-naïve study subjects with potential distinct genetic, clinical and immunological phenotypes.
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Exploratory and confirmatory biomarker validation study designs.
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Organ-specific or complete histology and pathology evaluation.
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Cellular, histologic and immunologic phenotyping (immuno-assays, immunopharmacology and flow cytometry).
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Concurrent standard pharmacokinetic or dedicated study designs.
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Genetic, small molecule and protein-based biomarkers.
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Tissue-specific efficacy biomarker levels by biosampling, biopsy or microdialysis.