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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.2Thisgu
2、idancealsoprovidesrecommendationsaboutsubmittingdevelopmental,manufacturing,andlabelinginformationforchewabletabletsthatmustbeapprovedbyCDERbeforetheycanbedistributed.Therecommendationsinthisguidanceapplymainlytonewdrugapplications(NDAs),abbreviatednewdrugapplications(ANDA
3、s),3andcertainchemistry,manufacturing,andcontrols(CMC) supplementstotheseapplications.4someoftherecommendationsaboutthesubmissionofdevelopmentalinformationmayalsoapplytoinvestigationalnewdrugapplications(INDs).Therecommendationsaboutassessingcriticalqualityattributesapplyt
4、oallchewabletabletsforhumanuse,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）3.专业学习资料.........和一些化学、生产和质控（CMC）补充申请4。某些建议同样适合于研究性新药申请（即新药临床申请，INDs）。关于评估关键质量属性
5、的建议适用于所有人用咀嚼片，包括非申请产品。Ingeneral,FDA’sguidancedocumentsdonotestablishlegallyenforceableresponsibilities.Instead,guidancesdescribetheAgency’scurrentthinkingonatopicandshouldbeviewedonlyasrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.Theuseofthewords
6、houldinAgencyguidancesmeansthatsomethingissuggestedorrecommended,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。II.BACKGROUNDII.背景Chewabletabletsareanimmediaterelease(IR)oraldosageformintendedtobechewedandthenswallowedbyt
7、hepatientratherthanswallowedwhole. Theyshouldbedesignedtohaveapleasanttasteandbeeasilychewedandswallowed. Chewabletabletsshouldbesafeandeasytouseinadiversepatientpopulation,pediatric,adult,orelderlypatients,whoareunableorunwillingtoswallowintacttabletsduetothesizeofthetabl
8、etordifficultywithswallowing.Theavailabilityofsafe,easy-to-use.专业学习资料.........dosageforms
