Generic Drug Dissolution.pdf

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1、TABLETSCRORALDISSOLUTION&BIOSTUDYCHAPTER15GenericDrugDissolutionandReferenceListedDrugissolutionisakeyrequirementD[1].Thetypeofdissolutionstudiesduringdrugdevelopment,batch-to-considerednecessarytofullyevaluatebatchqualitycontrol,productyourformulateddrugagainstth

2、eRLDregistrationandevaluatingthethathasbeenselected(Ref.Graph1&comparativedissolutionprofileGraph2,page215/216)demonstrateinformationrequiredforIVIVRealtimeandacceleratedstabilitystudyCorrelationsandtheBioequivalenceprofiles.section(VI)oftheANDAsubmission.[2]Wheth

3、eritispossibletoestablishEvaluatingwhetheryourfirmsgenericanIVIVCin-vitro,in-vivocorrelationdrugwillpasstheBiostudyfirsttimeisa(seeflowchartbelow)betweenyourkeyrequirement.Theprimarygoalistodrugandtheintendedbioequivalenceensurethatthegenericdrugissimilartostudyne

4、cessaryforfilingwiththeFDA.thereferencedrug.Knowingthereferencedrugsoverall¨ValidatedDissolutionMethoddissolutionprofileandageingAssayMethods:parametersarecriticalinputdataAfullyvalidatedDissolutionassayrequirements.methodisessentialtoobtainmeaningfulresultsfromac

5、omparativedissolutionThissectioncombinestherecentprofile(CDP)betweentheGenericanddevelopmentsindissolutionTestingandRLD.datacorrelationofSUPAC,IVIVCandPrudentdevelopmentlaboratorieswillBCStoproduceaworkingmodelonevaluateseveralCDPsusingmulti-pointaccessingsimilari

6、tybetweenyourdrugandmediaprofileswithmultiple(3)andthereferencelisteddrug(RLD)batches,hopefullywithdifferentFiveessentialstepsyourdevelopmentmanufacturingdatesandthusassessingunitcandotoachievethisgoal?miscellaneousproductages.¨DrugClassificationValidateddissoluti

7、onmethodClassifythedrugproductaccordingtorequirementsarehighlightedintable2.itssolubilityandpermeability.¨MultipointDissolutionProfilesDistinguishnarrow(25drugs)andnon-narrowtherapeuticrangedrugsaswell.AleastthreedifferentbatchlotsoftheThisclassificationwillfurnis

8、htwousefulRLDusingamultipointdissolutionprofilesshouldbeperformed.(Seeaspects;ReferencesAttached).HandbookofPharmaceuticalChapter:15.46GenericDevelopmen