fda發(fā)布咀嚼片關(guān)鍵質(zhì)量屬性指導(dǎo)原則

1、FDA發(fā)布咀嚼片關(guān)鍵質(zhì)量屬性指導(dǎo)原則（中英文對(duì)照）發(fā)布咀嚼片關(guān)鍵質(zhì)量屬性指導(dǎo)原則（中英文對(duì)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(chǎn)者提供了藥品審評(píng)研究中心(CD

5、ER)對(duì)人用咀嚼片在研發(fā)過程中應(yīng)評(píng)估的關(guān)鍵質(zhì)量屬性的當(dāng)前想法2。該指南也提供了必須向CDER提交并被其批準(zhǔn)的咀嚼片的研發(fā)、生產(chǎn)及說明書信息的建議。該指南的這些建議主要針對(duì)新藥申請(qǐng)(NDAs)、仿制藥申請(qǐng)(As尸和一些化學(xué)、生產(chǎn)和質(zhì)控(CMC)補(bǔ)充申請(qǐng)。某些建議同樣適合于硏究性新藥申請(qǐng)(即新藥臨床申請(qǐng)，INDs)。關(guān)于評(píng)估關(guān)鍵質(zhì)量屬性的建議適用于所有人用咀嚼片包括非申請(qǐng)產(chǎn)品。IngeneralFDAsguidancedocumentsdo

6、notestablishlegallyenfceableresponsibilities?InsteadguidancesdescribetheAgencyscurrentthinkingonatopicshouldbeviewedonlyasrecommendationsunlessspecificregulatystatutyrequirementsarecited.TheuseofthewdshouldinAgencyguidan

7、cesmeansthatsomethingissuggestedrecommendedbutnotrequired.通常FDA的指導(dǎo)文件不具有法律強(qiáng)制性，指南中描述的主題僅代表FDA機(jī)構(gòu)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(dǎo)原則，但不是必須的。evidencedbyinstancesofincompletemonitingofallrelevantcriticalqualityattributest

8、heuseofwidelyrangingvaluesthatwerenotjustifiedasacceptancecriteria.Inadditionawidevariationinanalyticalprocedureshasbeenrepted.789咀嚼片的不良反應(yīng)包括患者整片吞咽或不完全咀嚼導(dǎo)致的胃腸道(GI)(5且塞以及片劑過硬導(dǎo)致牙齒損傷和假牙破損6o也應(yīng)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(zhǔn)的很多咀嚼片來

9、看，許多產(chǎn)品對(duì)硬度、崩解時(shí)限、溶出度等關(guān)鍵質(zhì)量屬性的考察仍不充分，例如，對(duì)所有相關(guān)的關(guān)鍵質(zhì)量屬性監(jiān)管不完全，或質(zhì)量指標(biāo)范圍很寬泛但未證明其在可接受的標(biāo)準(zhǔn)之內(nèi)。此外，據(jù)報(bào)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(shí)應(yīng)考慮的關(guān)鍵質(zhì)量屬性、可選擇的合適的可接受標(biāo)準(zhǔn)、產(chǎn)品有效期內(nèi)的有意義的產(chǎn)品性能指標(biāo)。III.DISCUSSIONIII?討論討論Avarietyofphysicalacteristicsshouldbeconsider

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