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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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Celerion

Cliantha Research

Lubrizol Life Science Health

Nuvisan GmbH

PAREXEL International Corporation

Quotient Sciences

Sai Life Sciences Limited

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INDIA

UNITED KINGDOM

UNITED STATES

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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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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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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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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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The ADME (Absorption, Distribution, Metabolism and Excretion) Suite includes new state-of-the-art equipment and laboratory space to perform on-site scintillation counting allowing for radioactivity recovery results to be delivered in real-time.

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Nuvisan supports you with DMPK/ADME services throughout the discovery & development phases including Tailor-made “phase 0” in vitro & in vivo packages, i.e. in vitro metabolism, CYP interactions, absorption, distribution, PK/ADME in rodents & non-rodents.

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Cliantha Research' provides pharmacokinetic & pharmacodynamic bioequivalence studies as part of BA-BE/Phase-I. They also offer SAD & MAD studies, vasoconstriction & dose response (DRC) studies, In-vitro population bioequivalence (PBE), etc.

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Frequently, our Clients find their commercial dosage form is not appropriate for non-clinical testing. For developers in need of formulations specifically for toxicology and/or pharmacokinetic studies, we have the solution.

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