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Bioanalytical Core laboratory (CHOP)

Directors: Moorthy, Ganesh S., PhD; Zuppa, Athena F., MD, MSCE

Summary:

The Bioanalytical Core (BCL-CORE) laboratory is a part of the newly established Center for Clinical Pharmacology. The Bioanalytical Core provides quantitative bioanalytical services (analysis of small molecule drugs, metabolites and biomarkers in blood, serum, plasma, urine, ultrafiltrate, micro-dialysate, dried blood spot (DBS) and tissue homogenates) that are used for drug discovery and development.

The Bioanalytical Core performs method validations, partial validations, cross-matrix validations, or combination of them required to meet project needs. Validation studies are performed in accordance with the US FDA Guidance for Industry, Bioanalytical Method Validation. The core has developed assays for investigational and marketed drugs used for pain, oncology, cardiology and infectious diseases. These assays are typically used to support pediatric drug discovery and development.

Validated Assays:

-- Dexmedetomidine
-- Cefazolin
-- Cefepime
-- Fluconazole
-- Amicar
-- Midazolam and 1 and 4-hydroxymidazolam metabolites
-- Morphine, morphine-3-glucuronide and morphine-6-glucuronide
-- Ketamine and Norketamine
-- Milrinone
-- Actinomycin D
-- Vincristine
-- Alisertib (MLN8237)
-- Efavirenz
-- Aprepitant (EMEND IV)
-- Tenofovir

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Services

  • Services ( Analysis service )

    -- Assay development and rapid sample analysis for preclinical studies
    -- Assay development, validation and sample analysis for clinical studies
    -- Plasma protein binding of small molecule drugs and metabolites
    -- Stability studies for drugs in various formulations
    -- Pre-study design and label preparation for clinical studies using Watson LIMS


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Last updated: 2020-02-10T14:29:48.353-05:00

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The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016