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1、FDA发布咀嚼片关键质量属性指导原则（中英文对照）I.INTRODUCTIONI•引言ThisguidanceprovidesmanufacturersofchewabletabletsforhumanusewiththeCenterforDrugEvaluationandResearch's(CDER)currentthinkingonthecriticalqualityattributesthatshouldbeassessedduringthedevelopmentofthesedrugproducts.2Thisguidaneealsopro
2、videsrecommendationsaboutsubmittingdevelopmental,manufacturing,andlabelinginformationforchewabletabletsthatmustbeapprovedbyCDERbeforetheycanbedistributed.Therecommendationsinthisguidanceapplymainlytonewdrugapplications(NDAs),abbreviatednewdrugapplications(ANDAs),3andcertainchem
3、istry,manufacturing,andcontrols(CMC)supplementstotheseapplications4someoftherecommendationsaboutthesubmissionofdevelopmentalinformationmayalsoapplytoinvestigationalnewdrugapplications(INDs).Therecommendationsaboutassessingcriticalqualityattributesapplytoallchewabletabletsforhum
4、anuse,includingnon-applicationproducts.本指南向生产者提供了药品审评研究中心(CDER)对人用咀嚼片在研发过程中应评估的关键质量属性的当前想法2。该指南也提供了必须向CDER提交并被其批准的咀嚼片的研发、生产及说明书信息的建议。该指南的这些建议主要针对新药申请(NDAs)、仿制药申请(ANDAs尸和一些化学、生产和质控(CMC)补充申请°。某些建议同样适合于硏究性新药申请(即新药临床申请，INDs)。关于评估关键质量属性的建议适用于所有人用咀嚼片,包括非申请产品。Ingeneral,FDA'sguidancedo
5、cumentsdonotestablishlegallyenforceableresponsibilities・Instead,guidancesdescribetheAgency'scurrentthinkingonatopicandshouldbeviewedonlyasrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.TheuseofthewordshouldinAgencyguidancesmeansthatsomethingissuggestedo
6、rrecommended,butnotrequired.通常,FDA的指导文件不具有法律强制性，指南中描述的主题仅代表FDA机构目前的看法，只作为建议，除非是引用具体的法规或条例要求。建议或推荐使用该指导原则，但不是必须的。I.BACKGROUNDII•背景Chewabletabletsareanimmediaterelease(IR)oraldosageformintendedtobechewedandthenswallowedbythepatientratherthanswallowedwhole.Theyshouldbedesignedtoha
7、veapleasanttasteandbeeasilychewedandswallowed.Chewabletabletsshouldbesafeandeasytouseinadiversepatientpopulation,pediatric,adult,orelderlypatients,whoareunableorunwillingtoswallowintacttabletsduetothesizeofthetabletordifficultywithswallowing.Theavailabilityofsafe,easy-to・usedos
8、ageformsisimportantinclinicalpractice.Chewabletabletsa
