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Drug Metabolism and Pharmacokinetics (DMPK)

Our DMPK department has established various in vitro assays that help our clients efficiently and cost-effectively conduct compound characterizations of lead molecules. Our in vitro assays include metabolic stability using microsome/s9 and hepatocytes, MDCK and Caco-2 cell permeability, plasma protein binding, CYP450 (3A4, 1A2, 2D6, 2C9, 2C19, 2E1) inhibition, time-dependent inhibition, reactive metabolite screening, and metabolite identification.

Our experienced scientists can perform the following studies: preclinical ADME/PK/TK, lead compound PK screening and PK/PD studies, formulation evaluations, bioavailability assessment, dosing linearity assessment, determination of mass balance and tissue distribution, metabolic profiling and metabolite identification, the effects of food and gender on the pharmacokinetics, and drug-drug interaction (DDI) studies. We can also design or accommodate special protocols, including formulations.

Our bioanalysis division is fully equipped with state-of-the-art analytical instruments including several LC/MS/MS instruments. We can perform LC-MS/MS method development and validation following FDA guidance and biological samples analysis.

The DMPK department is capable of providing effective project support services including physicochemical property optimization, In vitro/In vivo correlation, human PK prediction, PK and PK/PD simulation and modeling, and authoring the DMPK section for IND.

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