Center for Pharmacokinetics and Drug Metabolism
2014-07-21 23:26:35 Author:admin
     
     The Center of Drug Metabolism and Pharmacokinetics (DMPK) has integrated research platforms to support preclinical ADME studies of small molecules in drug discovery and development. DMPK Center is equipped with a variety of modern instruments and animal facilities for in vivo PK and in vitro drug metabolism studies.
     The Center of DMPK is capable of conduct of pharmacokinetic and tissue distribution studies in multiple species (dog, rabbit, rat, mouse and nude mouse) and through multi-path administrations (PO, IV, SC, SL, IP, and IM). The center also performs in vivo metabolite identification and profiling in various matrices (blood, plasma, urine, feces and bile). Special PK studies using surgical animal models are also performed. Rats with bile duct catheterization, jugular or carotid artery catheterization, or hepatic portal vein catheterizations are surgically prepared for mass balance studies, or for evaluation of first-path effect; a technique for collection of cerebrospinal fluid (CSF) from live rats has been developed for CNS PK studies. PK studies in monkeys, mini-pigs are conducted through collaboration with universities, research institutions and CROs.
     The center has established a complete platform for in vitro ADME evaluation to support new drug discovery, development and IND filing. The platform includes metabolic stability and metabolite identification in liver microsomes or S9 fractions, stability in plasma or blood, plasma-blood partition ratio, plasma protein binding, inhibition of CYP enzymes, CYP phenotyping, and GSH trapping of reactive metabolites. Studies such as Caco-2 permeability, transporter (P-gp, BCRP, OATs, OCTs, and OATPs) interactions and CYP induction are collaborated with universities, research institutions and CROs.
    The center conducts toxicokinetic studies for toxicity species selection and PK/PD model predication in collaboration with departments of Toxicology and Pharmacology. Based on in vivoin vitro correlations in multiple preclinical species, suitable species are selected for long-term toxicity studies, and human clearance and effective dose are predicted.
     The laboratories of the center are equipped with state of the art equipments such as two API-4500 QTRAP LC-MS/MS, one API-4000 LC-MS/MS, Beckman high-speed refrigerated centrifuge, Thermostatic shaking incubator, -80 ºC freezers and highly sensitive electronic balance. WinNonlin software is used to calculate pharmacokinetic parameters.

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