Summary of a Bioavailability Or Bioequivalence Study

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Summary of a bioavailability or bioequivalence study

Part 1 - Study identification

Part 2 - Study type

• Apharmacokineticstudyconcernsthepropertiesofthedrugwhereasabioavailabilitystudyconcernstheproperties of specificformulationsor ofdifferent routesofadministration. Afoodstudyisconsidered to beabioavailabilitystudy.YouareencouragedtocontacttheTGAtodiscussstudiesifthisisnotclearforagivensubmission

Part 3 - Product details

Fortrialscomparinganewproductwiththatofacompetitor(e.g.comparisonofacontrolledreleaseproductwithanimmediatereleasebrandalreadyonthemarketinAustralia,orcomparisonofagenericwithanAustralianmarketleader),stateinwhatcountryandunderwhatcircumstancesthecompetitor’sbatchwasobtained.

Theformulationsandbatchnumbersofallproductsusedinthetrial

If yes, detail which

Part 4 - Quality control

Qualitycontroldataareprovidedforeachbatchofeachproductusedinthetrial,including:

• assayforthebatchand,whererelevant,dissolutionrateresults

• particlesizedistributiondataforthe APIusedtomanufacturethebatch,whererelevant

Thestudyreportissignedbytheprincipalinvestigator

Part 5 - Assay details

Detailsareprovidedoftheassaymethodanditsvalidation,including:

• descriptionoftheassaymethod(inbloodetc.)

• pre-studyvalidationprocedures

• withinstudyvalidation(asperformedbythetrialist)

• decisioncriteriaforacceptanceofeachanalyticalrun

Part 6 - Individual subject

Individualassayresultsforallsamplingtimesforeachsubjectandforeachtreatment

(Reportspresentedwithoutindividualpatientdatawillnotnormallybeevaluable)

Tabulationsofthederivedparametersforindividualsubjects,suchasCmax;Tmax;AUC0-inf;t1/2orkel;cumulativeurinaryexcretionetc.

Graphsofconcentration-timedatahavebeenprovided:

• foreachindividualsubject

• forthemeanofeachtreatment

Part 7 - Statistical analysis

Theresultsofthestatisticalanalysis

Ifanyofthedataindicatedpreviouslyarenotprovided,pleaseexplainwhy:

Summary of a bioavailability or bioequivalencestudy(August 2014)

For official use onlyPage 1 of 3