157
Views
5
CrossRef citations to date
0
Altmetric
Original Research

Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers

, , , , , , & show all
Pages 303-311 | Published online: 24 Jul 2013

References

  • European Medicines AgencyGuideline on the investigation of bioequivalence2010 Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdfAccessed July 24, 2012
  • Del TaccaMPasqualettiGDi PaoloALack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteersBr J Clin Pharmacol200968344219660001
  • CrawfordPFeelyMGubermanAKramerGAre there potential problems with generic substitution of antiepileptic drugs? A review of issuesSeizure20061516517616504545
  • BergMJGrossRATomaszewskiKJZingaroWMHaskinsLSGeneric substitution in the treatment of epilepsy: case evidence of breakthrough seizuresNeurology20087152553018695164
  • LeLorierJDuhMSParadisPEClinical consequences of generic substitution of lamotrigine for patients with epilepsyNeurology2008702179218618505997
  • MastorakiEMichalopoulosAKriarasIIncidence of postoperative infections in patients undergoing coronary artery bypass grafting surgery receiving antimicrobial prophylaxis with original and generic cefuroximeJ Infect200856353917983660
  • HalkinHShapiroJKurnikDLoebsteinRShalevVKokiaEIncreased warfarin doses and decreased international normalized ratio response after nationwide generic switchingClin Pharmacol Ther20037421522112966365
  • ElkoshiZBehrDMirimskyATsvetkovIDanonAMultiple-dose studies can be a more sensitive assessment for bioequivalence than single-dose studies: the case with omeprazoleClin Drug Invest200222585592
  • ShimataniTInoueMKuroiwaTXuJMienoHTazumaSAcid-suppressive effects of generic omeprazole: comparison of three brands of generic omeprazole with original omeprazoleDig Liver Dis20063855455916524789
  • ReiffelJAIssues in the use of generic antiarrhythmic drugsCurr Opin Cardiol200116232911124715
  • ChenuFBattenLAZernigGLadstaetterEHébertCBlierPComparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover studyJ Clin Psychiatry20097095896619653973
  • MeredithPAPotential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt formsCurr Med Res Opin2009252179218919601710
  • ChassaingCSchmidtJEschalierACardotJMDubrayCHyperalgesia induced by cutaneous freeze injury for testing analgesics in healthy volunteersBr J Clin Pharmacol2006438939716542199
  • MeinekeITürckDPopulation pharmacokinetic analysis of meloxicam in rheumatoid arthritis patientsBr J Clin Pharmacol200355323812534638
  • SteningKErikssonOWahrenLBergGHammarMBlomqvistAPain sensations to the cold pressor test in normally menstruating women: comparison with men and relation to menstrual phase and serum sex steroid levelsAm J Physiol Regul Integr Comp Physiol2007293R1711R171617652363
  • RingCVeldhuijzen van ZantenJJKavussanuMEffects of sex, phase of the menstrual cycle and gonadal hormones on pain in healthy humansBiol Psychol20098118919119393713
  • KowalczykWJSullivanMAEvansSMBisagaAMVosburgSKComerSDSex differences and hormonal influences on response to mechanical pressure pain in humansJ Pain20101133034219853526
  • TeepkerMPetersMVedderHSchepelmannKLautenbacherSMenstrual variation in experimental pain: correlation with gonadal hormonesNeuropsychobiology20106113114020110738
  • GschwendMHErenmemişoğluAMartinWTamurUKanzikIHincalAAPharmacokinetic and bioequivalence study of meloxicam tablets in healthy male subjectsArzneimittelforschung20075726426817598697
  • TangsucharitPKampanJKanjanawartSBioequivalence study of two meloxicam tablet formulations after single-dose administration in healthy Thai male volunteersInt J Clin Pharmacol Ther20094763864219825327
  • HasanSMShoaibMHHassanFRehmanIUBioequivalence studies of two brands of meloxicam tablets in healthy Pakistani volunteersPak J Pharm Sci20092219920419339233
  • AhmadMMurtazaGAkhtarNBioequivalence study of two brands of meloxicam tablets in healthy human Pakistani male subjectsActa Pol Pharm20116811511921485709
  • PasqualettiGGoriGBlandizziCDel TaccaMHealthy volunteers and early phases of clinical experimentationEur J Clin Pharmacol20106664765320461363
  • European Medicines AgencyGuideline for good clinical practice2002 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdfAccessed July 24, 2012
  • World Medical Association Declaration of Helsinki 2008Ethical principles for medical research involving human subjects2008 Available from: http://www.wma.net/en/30publications/10policies/b3/17c.pdfAccessed July 24, 2012
  • BaeJWKimMJJangCGLeeSYDetermination of meloxicam in human plasma using a HPLC method with UV detection and its application to a pharmacokinetic studyJ Chromatogr B Analyt Technol Biomed Life Sci20078596973
  • PolilloMTasciniCLastellaMA rapid high-performance liquid chromatography method to measure linezolid and daptomycin concentrations in human plasmaTher Drug Monit20103220020520216115
  • MeyerRACampbellJNRajaSNPeripheral neural mechanisms of nociceptionWallPDMelzackRBonicaJJTextbook of PainNew YorkChurchill Livingstone19951344
  • SchuirmannDJA comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailabilityJ Pharmacokinet Biopharm1987156576803450848
  • ChenMLShahVPatnaikRBioavailability and bioequivalence: an FDA regulatory overviewPharm Res2001181645165011785681
  • YuLXAmidonGLPolliJEBiopharmaceutics classification system: the scientific basis for biowaiver extensionsPharm Res20021992192512180542
  • World Health OrganizationProposal to waive in vivo bioequivalence requirements for the WHO model list of essential medicines: immediate release, solid oral dosage forms2005 Available from: http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS04_109Rev1_Waive_invivo_bioequiv.pdfAccessed July 24, 2012
  • MeredithPBioequivalence and other unresolved issues in generic drug substitutionClin Ther2003252875289014693311
  • TürckDRothWBuschUA review of the clinical pharmacokinetics of meloxicamBr J Rheumatol199635Suppl 113168630630
  • Marcelín-JiménezGHernándezJAAngelesAPBioequivalence evaluation of two brands of meloxicam tablets (Promotion and Mobicox): pharmacokinetics in a healthy female Mexican populationBiopharm Drug Dispos20052616717115841494
  • DaviesNMSkjodtNMClinical pharmacokinetics of meloxicam. A cyclo-oxygenase-2 preferential nonsteroidal anti-inflammatory drugClin Pharmacokinet19993611512610092958
  • PerryRPerspectives on the bioequivalence and therapeutic equivalence of generic formulations: an overview of the landscapeClin Ther2010321796179721194603
  • AlvarezCAMascarenasCTimmermanIIncreasing psychosis in a patient switched from Clozaril to generic clozapineAm J Psychiatry2006163474616585457