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    Pharmacokinetics (PK) characterizes the movement of a drug through the body, with parameters describing its absorption, distribution, bioavailability, metabolism, and excretion over time. Pharmacodynamics (PD) characterizes the body’s response to the drug and is often described by biochemical or molecular interactions or physiological effects of a drug. Understanding the exposure-response relationship (PK/PD) is key to the development and approval of every drug. PK and PD analyses are used to c

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    • PHARMACOKINETICS / PHARMACODYNAMICS / PHARMACOMETRICS
    • PHASE I / IIA
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    Quotient Sciences

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    CPhI North America 2021

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    14C ADME / Mass Balance

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    - Service Details

    Quotient has the experience and expertise to seamlessly deliver several studies involving Bioavailability, dose proportionality, absolute bioavailability, Bioequivalence, 14C ADME / Mass Balance, Thorough QT (TQT) / cardiac safety, Pharmacodynamics, etc.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics

    Celerion

    • FDA

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    UNITED STATES United States

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    Radiolabeled ADME Studies

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    In response to a growing interest in conducting human 14C-radiolabeled ADME studies earlier in drug development, Celerion has expanded its ADME suite in Lincoln, Nebraska.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics

    Celerion

    • FDA

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    UNITED STATES United States

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    14C-Radiolabeled Microtracer Studies

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    Celerion’s clinic in Lincoln, Nebraska, is the only Phase I facility in North America with proven experience to release radiolabeled drug to regulatory standards that has been formulated on site for intravenous use in humans. This is required to perform assessments of absolute bioavailability

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics

    PAREXEL International Corporation

    • FDA

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    Clinical PK/PD and Pharmacometrics Services

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    PAREXEL’s global team of experienced clinical pharmacokineticists and pharmacometricians offer unsurpassed expertise in Clinical PK/PD and Pharmacometrics, from pre-clinical to Phase III studies.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics

    Celerion

    • FDA

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    UNITED STATES United States