Model-dependent pharmacokinetic analysis of enalapril administered to healthy adult volunteers using orodispersible minitablets for use in pediatrics

References

• PonikowskiPVoorsAAAnkerSD2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failureEur Heart J201637272129220027206819
   PubMed Web of Science ®Google Scholar
• HsuDTPearsonGDHeart failure in children: Part I: history, etiology, and pathophysiologyCirc Heart Fail200921637019808316
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration Modernization Act (FDAMA) of 1997Food and Drug Administration Authority1997 Available from: https://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdfAccessed August 20, 2018
   Google Scholar
• Regulation (EC) No 1901/2006 of the European parliament and of the council. The European parliament and of the council of 12 December 2006 Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdfAccessed January 11, 2019
   Google Scholar
• NandiDRossanoJWEpidemiology and cost of heart failure in childrenCardiol Young20152581460146826675591
   PubMed Web of Science ®Google Scholar
• FernandezEPerezRHernandezATejadaPArtetaMRamosJTFactors and mechanisms for pharmacokinetic differences between pediatric population and adultsPharmaceutics201131537224310425
   PubMedGoogle Scholar
• KearnsGLAbdel-RahmanSMAlanderSWBloweyDLLeederJSKauffmanREDevelopmental pharmacology – drug disposition, action, and therapy in infants and childrenN Engl J Med2003349121157116713679531
   PubMed Web of Science ®Google Scholar
• BeggsSThompsonANashRTompsonAPetersonG17th Expert Committee on the Selection and Use of Essential Medicines GenevaCardiac failure in children32009 Available from: https://www.who.int/selection_medicines/committees/expert/17/application/paediatric/Paed_Cardiac_Failure_Review.pdfAccessed January 11, 2019
   Google Scholar
• BurchMDevliegerHGarciaAEuropean Medicines AgencyReport on the Expert Group Meeting of Paediatric Heart FailureLondon29 November 2010 Available from: https://www.ema.europa.eu/documents/other/report-expert-group-meeting-paediatric-heart-failure-london-29-november-2010_en.pdfAccessed January 11, 2019
   Google Scholar
• LewisABChabotMThe effect of treatment with angiotensin-converting enzyme inhibitors on survival of pediatric patients with dilated cardiomyopathyPediatr Cardiol19931419128456034
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyPresentations2017 Available from: http://www.ema.europa.eu/ema/Accessed August 20, 2018
   Google Scholar
• Summary of product characteristics, SPC was annexed to the commission decisionCPMP/3175/03/2003113 Available from: www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Renitec_30/WC500010751.pdfAccessed August 20, 2018
   Google Scholar
• BrionFNunnAJRieutordAExtemporaneous (magistral) preparation of oral medicines for children in European hospitalsActa Paediatr2007924486490
   Google Scholar
• LopezFLErnestTBTuleuCGulMOFormulation approaches to pediatric oral drug delivery: benefits and limitations of current platformsExpert Opin Drug Deliv201512111727174026165848
   PubMed Web of Science ®Google Scholar
• BatchelorHKMarriottJFFormulations for children: problems and solutionsBr J Clin Pharmacol201579340541825855822
   PubMed Web of Science ®Google Scholar
• StoltenbergIBreitkreutzJOrally disintegrating mini-tablets (ODMTs) – a novel solid oral dosage form for paediatric useEur J Pharm Biopharm201178346246921324357
   PubMed Web of Science ®Google Scholar
• Wittlieb-WeberCALinKYZaoutisTEPediatric versus adult cardiomyopathy and heart failure-related hospitalizations: a value-based analysisJ Card Fail2015211768225451708
   PubMed Web of Science ®Google Scholar
• World Health OrganizationReport of the Informal Expert Meeting on Dosage Forms of Medicines for Children200812115 Available from: http://www.who.int/selection_medicines/committees/expert/17/application/pediatric/Dosage_form_reportDEC2008.pdfAccessed August 20, 2018
   Google Scholar
• EMEAGuideline on pharmaceutical development of medicines for paediatric use guideline on pharmaceutical development of medicines for paediatric useEMEA201344123
   Google Scholar
• HEALTH 2013.4.2-1 – Investigator-driven clinical trials for off-patent medicines using innovative, age-appropriate formulations and/or delivery systems Available from: https://cordis.europa.eu/programme/rcn/18549_en.htmlAccessed August 13, 2018
   Google Scholar
• FDABioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations (Draft)2014 Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm389370.pdfAccessed August 20, 2018
   Google Scholar
• MuirKTNonlinear least-squares regression analysis in pharmacokinetics: application of a programmable calculator in model parameter estimationComput Biomed Res19801343073167408454
   PubMedGoogle Scholar
• KiersHALWeighted least squares fitting using ordinary least squares algorithmsPsychometrika1997622251266
   Web of Science ®Google Scholar
• MotulskyHChristopoulosAFitting models to biological data using linear and nonlinear regressionSan DiegoGraphPad Software Inc.2005
   Google Scholar
• PeckCCSheinerLBNicholsAIThe problem of choosing weights in nonlinear regression analysis of pharmacokinetic dataDrug Metab Rev1984151–21331486745079
   PubMed Web of Science ®Google Scholar
• GabrielssonJWeinerDPharmacokinetic Pharmacodynamics Data Analysis: Concepts and Applications3rd edSwedenSwedish Academy of Pharmaceutical Sciences2000
   Google Scholar
• Food and Drug AdministrationGuidance for Industry: Bioanalytical Method ValidationUS Dep Heal Hum Serv20015410 Available from: http://www.labcompliance.de/documents/FDA/FDA-Others/Laboratory/f-507-bioanalytical-4252fnl.pdfAccessed August 20, 2018
   Google Scholar
• IchICH Topic Q2 (R1) Validation of Analytical Procedures: Text and MethodologyInt Conf Harmon20051994vember 199617 Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdfAccessed August 20, 2018
   Google Scholar
• MatalkaKArafatTHamadMJehanliADetermination of enalapril and enalaprilat by enzyme linked immunosorbent assays: application to pharmacokinetic and pharmacodynamic analysisFundam Clin Pharmacol200216323724412165071
   PubMed Web of Science ®Google Scholar
• GuQChenXZhongDWangYSimultaneous determination of enalapril and enalaprilat in human plasma by liquid chromatography-tandem mass spectrometryJ Chromatogr B Analyt Technol Biomed Life Sci20048131–2337342
   PubMed Web of Science ®Google Scholar
• HedayaMABasic Pharmacokinetics2nd edNew YorkTaylor & Francis Group2012
   Google Scholar
• PortolésAPuerroMTerleiraAA new high-absorption-rate paracetamol 500-mg formulation: a comparative bioavailability study in healthy volunteersCurr Ther Res Clin Exp200364740141124944391
   PubMed Web of Science ®Google Scholar
• Report TWho expert Committee on specifications for pharmaceutical preparations. Annex 52005 Available from: http://apps.who.int/iris/bitstream/handle/10665/272452/9789241210195-eng.pdfAccessed August 20, 2018
   Google Scholar
• VerbeeckRKKanferILöbenbergRBiowaiver Monographs for immediate-release solid oral dosage forms: enalaprilJ Pharm Sci201710681933194328435140
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.govEthicare GmbH: National Library of Medicine (US)3092014 Identifier NCT02252692, Relative bioavailability study with enalapril in healthy volunteers; 2014. Available from: https://clinicaltrials.gov/ct2/show/NCT02252692?spons=Ethicare&rank=4Accessed August 20, 2018
   Google Scholar
• DokoumetzidisAMacherasPA century of dissolution research: from Noyes and Whitney to the Biopharmaceutics Classification SystemInt J Pharm20063211–211116920290
   PubMed Web of Science ®Google Scholar
• SavicRMJonkerDMKerbuschTKarlssonMOImplementation of a transit compartment model for describing drug absorption in pharmacokinetic studiesJ Pharmacokinet Pharmacodyn200734571172617653836
   PubMed Web of Science ®Google Scholar