fda發(fā)布咀嚼片關鍵質量屬性指導原則

1、FDA發(fā)布咀嚼片關鍵質量屬性指導原則（中英文對照）發(fā)布咀嚼片關鍵質量屬性指導原則（中英文對照）I.INTRODUCTIONI?引言引言ThisguidanceprovidesmanufacturersofchewabletabletsfhumanusewiththeCenterfDrugEvaluationResearchs(CDER)currentthinkingonthecriticalqualityattributesthatsh

2、ouldbeassessedduringthedevelopmentofthesedrugproducts.2ThisguidaneealsoprovidesrecommendationsaboutsubmittingdevelopmentalmanufacturinglabelinginfmationfchewabletabletsthatmustbeapprovedbyCDERbefetheycanbedistributed.The

3、recommendationsinthisguidanceapplymainlytonewdrugapplications(NDAs)abbreviatednewdrugapplications(As)3certainchemistrymanufacturingcontrols(CMC)supplementstotheseapplications4someoftherecommendationsaboutthesubmissionofd

4、evelopmentalinfmationmayalsoapplytoinvestigationalnewdrugapplications(INDs).Therecommendationsaboutassessingcriticalqualityattributesapplytoallchewabletabletsfhumanuseincludingnonapplicationproducts.本指南向生產者提供了藥品審評研究中心(CD

5、ER)對人用咀嚼片在研發(fā)過程中應評估的關鍵質量屬性的當前想法2。該指南也提供了必須向CDER提交并被其批準的咀嚼片的研發(fā)、生產及說明書信息的建議。該指南的這些建議主要針對新藥申請(NDAs)、仿制藥申請(As尸和一些化學、生產和質控(CMC)補充申請。某些建議同樣適合于硏究性新藥申請(即新藥臨床申請，INDs)。關于評估關鍵質量屬性的建議適用于所有人用咀嚼片包括非申請產品。IngeneralFDAsguidancedocumentsdo

6、notestablishlegallyenfceableresponsibilities?InsteadguidancesdescribetheAgencyscurrentthinkingonatopicshouldbeviewedonlyasrecommendationsunlessspecificregulatystatutyrequirementsarecited.TheuseofthewdshouldinAgencyguidan

7、cesmeansthatsomethingissuggestedrecommendedbutnotrequired.通常FDA的指導文件不具有法律強制性，指南中描述的主題僅代表FDA機構目前的看法，只作為建議，除非是引用具體的法規(guī)或條例要求。建議或推薦使用該指導原則，但不是必須的。evidencedbyinstancesofincompletemonitingofallrelevantcriticalqualityattributest

8、heuseofwidelyrangingvaluesthatwerenotjustifiedasacceptancecriteria.Inadditionawidevariationinanalyticalprocedureshasbeenrepted.789咀嚼片的不良反應包括患者整片吞咽或不完全咀嚼導致的胃腸道(GI)(5且塞以及片劑過硬導致牙齒損傷和假牙破損6o也應考慮咀嚼片引起的食道刺激這一潛在不良事件。從過去批準的很多咀嚼片來

9、看，許多產品對硬度、崩解時限、溶出度等關鍵質量屬性的考察仍不充分，例如，對所有相關的關鍵質量屬性監(jiān)管不完全，或質量指標范圍很寬泛但未證明其在可接受的標準之內。此外，據報道分析方法也存在很大差異了吧Thisguidaneedescribesthecriticalqualityattributesthatshouldbeconsideredwhendevelopingchewabletabletsrecommendsthattheedacc

10、eptancecriteriabeappropriatemeaningfulindicatsofproductperfmancethroughouttheshelflifeoftheproduct.本指南建議了開發(fā)咀嚼片時應考慮的關鍵質量屬性、可選擇的合適的可接受標準、產品有效期內的有意義的產品性能指標。III.DISCUSSIONIII?討論討論Avarietyofphysicalacteristicsshouldbeconsider

11、edinthemanufacturingprocessfchewabletablets.Anidealchewabletabletshouldbe:?Easytochew?Palatable(tastemaskedofacceptabletaste)?Ofappropriatesizeshape10?Abletodisintegratereadilytominimizeaspirationfacilitatedissolution.在咀