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BioIVT Inc naive normal human serum
Comparing clinical study specific predoses with the <t>naïve</t> donor validation data set. S/N percent depletion was calculated for 16 predose samples from a phase 1 clinical study and for 96 donor samples (48 healthy and 48 disease specific). The plot indicates that although baseline samples depleted a bit higher, they are still within the distribution of naïve donors from the DCP validation experiment
Naive Normal Human Serum, supplied by BioIVT Inc, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
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Comparing clinical study specific predoses with the naïve donor validation data set. S/N percent depletion was calculated for 16 predose samples from a phase 1 clinical study and for 96 donor samples (48 healthy and 48 disease specific). The plot indicates that although baseline samples depleted a bit higher, they are still within the distribution of naïve donors from the DCP validation experiment

Journal: The AAPS Journal

Article Title: Statistical and Bioanalytical Considerations for Establishing a Depletion Criterion for Specificity Testing During Immunogenicity Assessment of a Biotherapeutic

doi: 10.1208/s12248-013-9523-1

Figure Lengend Snippet: Comparing clinical study specific predoses with the naïve donor validation data set. S/N percent depletion was calculated for 16 predose samples from a phase 1 clinical study and for 96 donor samples (48 healthy and 48 disease specific). The plot indicates that although baseline samples depleted a bit higher, they are still within the distribution of naïve donors from the DCP validation experiment

Article Snippet: Pooled naïve normal human serum (PNHS) and serum from individual drug/biotherapeutic naïve human donors (healthy and disease specific) were obtained for use as assay matrix from Bioreclamation, Inc., Hicksville, NY.

Techniques: Biomarker Discovery