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Review
Received:12May2009Revised:24June2009Accepted:25June2009PublishedonlineinWileyInterscience:11September2009
()DOI10.1002/psc.1167
Qualityspecificationsforpeptidedrugs:a
regulatory-pharmaceuticalapproach
ValentijnVergote,aChristianBurvenich,bChristopheVandeWielec
andBartDeSpiegeleera∗
Peptidedrugs,asalltypesofpharmaceuticals,requireadequatespecifications(i.e.qualityattributes,proceduresandacceptance
criteria)aspartoftheirqualityassurancetoensurethesafetyandefficacyofdrugsubstances(i.e.activepharmaceutical
ingredients)anddrugproducts(i.e.finishedpharmaceuticaldosageforms).Compendialmonographsareupdatedregularlyto
keepupwiththemostrecentadvancesinpeptidesynthesis(e.g.reducedby-products)andanalyticaltechnology.Nevertheless,
currentlyappliedpharmacopoeialpeptidespecificationsarebarelyharmonizedyet(e.g.largedifferencesbetweentheEuropean
PharmacopoeiaandtheUnitedStatesPharmacopeia),increasingthemanufacturers’burdenofperforminganalyticalprocedures
indifferentways,usingdifferentacceptancecriteria.Additionally,thepeptidemonographsarenotalwaysconsistentwithina
singlepharmacopoeia.Inthisreview,wehighlightthemaindifferencesandsimilaritiesincompendialpeptidespecifications
(includingidentification,purityandassay).Basedoncomparison,andtogetherwithadditionalinformationfrompeptidedrug
substancemanufacturersandpublicevaluationreportsonregistrationfilesofnon-pharmacopoeialpeptidedrugs,aconsistent
c
monographstructureisproposed.Copyright2009EuropeanPeptideSocietyandJohnWileySons,Ltd.
Keywords:peptidedrugsubstance;qualityattributes;acceptancecriteria;regulatoryaffairs;ICHguidelines;Ph.Eur.andUSP
pharmacopoeialmonographs;relatedsubstancesthresholds
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