45
Views
1
CrossRef citations to date
0
Altmetric
Original Research

Detection of nanolevel drug metabolites in an organotypic culture of primary human hepatocytes and porcine hepatocytes with special reference to a two-compartment model

, &
Pages 5859-5872 | Published online: 26 Nov 2012

References

  • PaulSMMytelkaDSDunwiddieCTHow to improve R&D productivity: the pharmaceutical industry’s grand challengeNat Rev Drug Discov20109320321420168317
  • DiMasiJAHansenRWGrabowskiHGThe price of innovation: new estimates of drug development costsJ Health Econ200322215118512606142
  • http://www.fda.gov [homepage on the Internet]Innovation or stagnation: challenge and opportunity on the critical path to new medical productsSilver Spring, MDUS Food and Drug Administration2004 [updated October 20, 2010]. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htmAccessed May 10, 2011
  • HoldenADetecting and investigating drug induced adverse events: the International Serious Adverse Event Consortium’s experienceProceedings of the FDA/CDER/PhRMA/AASLD MeetingMarch 27, 2008 Available from: http://www.fda.gov/downloads/Drugs/Science Research/Research-Areas/ucm077482.pdfAccessed October 17, 2008
  • GaleEALessons from the glitazones: a story of drug developmentLancet200135792711870187511410214
  • Strengthening pharmacovigilance to reduce adverse effects of medicines [Memo]BrusselsEuropean Commission2008 Available from: http://ec.europa.eu/health/files/pharmacos/pharmpack_12_2008/memo_pharmacovigiliance_december_2008_en.pdfAccessed May 10, 2011
  • MakarovaSIHuman N-acetyltransferases and drug-induced hepatotoxicityCurr Drug Metab20089653854518680474
  • HughesBIndustry concern over EU hepatotoxicity guidanceNat Rev Drug Discov20087971919172685
  • FrederickCBObachRSMetabolites in safety testing: “MIST” for the clinical pharmacologistClinical Pharmacol Ther201087334535020107437
  • SmithDAObachRSMetabolites and safety: What are the concerns, and how should we address them?Chem Res Toxicol200619121570157917173370
  • FuraARole of pharmacologically active metabolites in drug discovery and developmentDrug Discov Today2006113–413314216533711
  • GiriSBaderAImproved preclinical safety assessment using micro-BAL devices: the potential impact on human discovery and drug attritionDrug Discov Today2011169–1038239721354326
  • GiriSNieberKBaderAHepatotoxicity and hepatic metabolism of available drugs: current problems and possible solutions in preclinical stagesExpert Opin Drug Metab Toxicol20106889591720367107
  • LeungLKalgutkarASObachRSMetabolic activation in drug-induced liver injuryDrug Metab Rev2012441183321939431
  • EmotoCMurayamaNRostami-HodjeganAYamazakiHMethodologies for investigating drug metabolism at the early drug discovery stage: prediction of hepatic drug clearance and P450 contributionCurr Drug Metab201011867868520973757
  • BaillieTACayenMNFoudaHDrug metabolites in safety testingToxicol Appl Pharmacol2002182318819612229863
  • PowleyMWFrederickCBSistareFDDeGeorgeJJSafety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450sChem Res Toxicol200922225726219170595
  • SmithDAObachRSMetabolites in safety testing (MIST): considerations of mechanisms of toxicity with dose, abundance, and duration of treatmentChem Res Toxicol200922226727919166333
  • NeddermanANMetabolites in safety testing: metabolite identification strategies in discovery and developmentBiopharm Drug Dispos200930415316219544286
  • VishwanathanKBabalolaKWangJObtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standardsChem Res Toxicol200922231132219067650
  • NaitoSFurutaSYoshidaTCurrent opinion: safety evaluation of drug metabolites in development of pharmaceuticalsJ Toxicol Sci200732432934117965548
  • US Food and Drug AdministrationGuidance for Industry: Safety Testing of Drug MetabolitesDraft GuidanceRockville, MDUS Food and Drug Administration, Center for Drug Evaluation and Research (CDER)2006
  • US Food and Drug AdministrationGuidance for Industry: Safety Testing of Drug MetabolitesRockville, MDUS Food and Drug Administration, Center for Drug Evaluation and Research (CDER)2008
  • PrueksaritanontTLinJHBaillieTAComplicating factors in safety testing of drug metabolites: kinetic differences between generated and preformed metabolitesToxicol Appl Pharmacol2006217214315217055014
  • SmithDAObachRSSeeing through the mist: abundance versus percentage. Commentary on metabolites in safety testingDrug Metab Dispos200533101409141715985503
  • AtrakchiAHInterpretation and considerations on the safety evaluation of human drug metabolitesChem Res Toxicol20092271217122019563206
  • BaillieTAApproaches to the assessment of stable and chemically reactive drug metabolites in early clinical trialsChem Res Toxicol200922226326619216579
  • LeclercqLCuyckensFMannensGSde VriesRTimmermanPEvansDCWhich human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical developmentChem Res Toxicol200922228029319183054
  • Davis-BrunoKLAtrakchiAA regulatory perspective on issues and approaches in characterizing human metabolitesChem Res Toxicol200619121561156317173368
  • HumphreysWGUngerSESafety assessment of drug metabolites: Characterization of chemically stable metabolitesChem Res Toxicol200619121564156917173369
  • ParkBKBoobisAClarkeSManaging the challenge of chemically reactive metabolites in drug developmentNat Rev Drug Discov201110429230621455238
  • LangschAGiriSAcikgozAJasmundIFrericksBBaderAInterspecies difference in liver-specific functions and biotransformation of testosterone of primary rat, porcine and human hepatocyte in an organotypical sandwich cultureToxicol Lett2009188317317919428196
  • WatanabeASakaiTSatoSClinical efficacy of lactulose in cirrhotic patients with and without subclinical hepatic encephalopathyHepatology1997266141014149397979
  • MakiTMonacoAPPorcine islet xenotransplantation utilizing a vascularized bioartificial pancreasAnn Transplant19972369719869867
  • DinsmoreJHManhartCRaineriRJacobyDBMooreANo evidence for infection of human cells with porcine endogenous retrovirus (PERV) after exposure to porcine fetal neuronal cellsTransplantation20007091382138911087157
  • BaderAKnopEKernA3-D coculture of hepatic sinusoidal cells with primary hepatocytes-design of an organotypical modelExp Cell Res199622612232338660959
  • BaderAZechKCromeOUse of organotypical cultures of primary hepatocytes to analyse drug biotransformation in man and animalsXenobiotica19942476236337975727
  • KernABaderAPichlmayrRSewingKFDrug metabolism in hepatocyte sandwich cultures of rats and humansBiochem Pharmacol19975477617729353130
  • SidhuJSLiuFOmiecinskiCJPhenobarbital responsiveness as a uniquely sensitive indicator of hepatocyte differentiation status: requirement of dexamethasone and extracellular matrix in establishing the functional integrity of cultured primary rat hepatocytesExp Cell Res2004292225226414697333
  • MaringkaMGiriSNieberKAcikgozABaderABiotransformation of diazepam in a clinically relevant flat membrane bioreactor model using primary porcine hepatocytesFundam Clin Pharmacol201125334335320618872
  • MaringkaMGiriSBaderAPreclinical characterization of primary porcine hepatocytes in a clinically relevant flat membrane bioreactorBiomaterials201031115617219818493
  • SeglenPOPreparation of isolated rat liver cellsMethods Cell Biol1976132983177845
  • HoogenboomLAPastoorFJClousWEHesseSEKuiperHAThe use of porcine hepatocytes for biotransformation studies of veterinary drugsXenobiotica19891911120712192618075
  • ElsdaleTBardJCollagen substrata for studies on cell behaviorJ Cell Biol19725436266374339818
  • AcikgozAKarimNGiriSSchmidt-HeckWBaderATwo compartment model of diazepam biotransformation in an organotypical culture of primary human hepatocytesToxicol Appl Pharmacol2009234217919118983865
  • ThompsonRAIsinEMLiYRisk assessment and mitigation strategies for reactive metabolites in drug discovery and developmentChem Biol Interact20111921–2657121074519
  • TujiosSFontanaRJMechanisms of drug-induced liver injury: from bedside to benchNat Rev Gastroenterol Hepatol20118420221121386809