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Exploratory assay development using human samples, for example, tissues or body fluids, are usually conducted under general human subject protection and privacy provisions implemented by academic institutions.
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Infectivity and virulence of the wild type, EVG016 and EVG017g was evaluated using a topical 5-dose bioassay with doses bracketing the approximate LD50 based on exploratory assays (see Methods).
An exploratory type assay is neither integral nor integrated.
Clinical sera from the Pfizer SA3Ag vaccine study (described below) were evaluated using the exploratory FBI assay.
In addition, cryopreserved samples were stored for further exploratory immunology assays, including analysis of soluble cytokines within the first week after vaccination.
The five phases of biomarker development include (1) preclinical exploratory (2) clinical assay validation (3) retrospective longitudinal (4) prospective screening and (5) cancer control.
Moreover, in exploratory analyses this assay appeared to be predictive of benefit from tamoxifen (low RS predicts benefit and high RS predicts resistance) and from chemotherapy (low RS predicts resistance and high RS predicts benefit) [ 19, 20].
Additional exploratory analyses of our assay on the effect of frozen storage, which found concordant results in all samples, indicated the possibility to store freshly collected samples for a longer period and to process them later.
Similar cell cycle morphology delay events were also observed upon quinine exposure (IC50 and IC90) in exploratory 12 hour follow up assay (Figure S2).
Exploratory behavior was observed using assay plates without stimuli, as shown in Figure 1.
The 3 labs operate under exploratory research conditions with qualified assays using established protocols (n = 2) or SOP (n = 1), and experiments were performed by trained personnel.
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