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Summary of a bioavailability or bioequivalence study

Part 1 - Study identification

Studyreporttitle
Report/protocolidentificationnumber
Volumewherethefulltrial reportislocated: / Pages:

Part 2 - Study type

Areyousurethisisabioavailabilityand/orbioequivalencestudy(andnotapharmacokineticstudy)? / Yes No:
  • Apharmacokineticstudyconcernsthepropertiesofthedrugwhereasabioavailabilitystudyconcernstheproperties of specificformulationsor ofdifferent routesofadministration. Afoodstudyisconsidered to beabioavailabilitystudy.YouareencouragedtocontacttheTGAtodiscussstudiesifthisisnotclearforagivensubmission

Part 3 - Product details

Drugproductstested / Dosageregimen

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

Theformulationsandbatchnumbersofallproductsusedinthetrial

arelocatedinVolumeNo: / Pages:
Wereanyoftheseformulationsidenticaltotheonewhichisthesubjectofthisregistrationapplication? / Yes No

If yes, detail which

Part 4 - Quality control

Qualitycontroldataareprovidedforeachbatchofeachproductusedinthetrial,including:

  • assayforthebatchand,whererelevant,dissolutionrateresults

Thesedataarelocatedin Volume No: / Pages:
  • particlesizedistributiondataforthe APIusedtomanufacturethebatch,whererelevant

Thesedataarelocatedin Volume No: / Pages:

Thestudyreportissignedbytheprincipalinvestigator

in Volume No: / Pages:

Part 5 - Assay details

Detailsareprovidedoftheassaymethodanditsvalidation,including:

  • descriptionoftheassaymethod(inbloodetc.)

Thesedataarelocatedin Volume No: / Pages:
  • pre-studyvalidationprocedures

Thesedataarelocatedin Volume No: / Pages:
  • withinstudyvalidation(asperformedbythetrialist)

Thesedataarelocatedin Volume No: / Pages:
  • decisioncriteriaforacceptanceofeachanalyticalrun

Thesedataarelocatedin Volume No: / Pages:

Part 6 - Individual subject

Individualassayresultsforallsamplingtimesforeachsubjectandforeachtreatment

arelocatedin Volume No: / Pages:

(Reportspresentedwithoutindividualpatientdatawillnotnormallybeevaluable)

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

arelocatedin Volume No: / Pages:

Graphsofconcentration-timedatahavebeenprovided:

  • foreachindividualsubject

in Volume No: / Pages:
  • forthemeanofeachtreatment

in Volume No: / Pages:

Part 7 - Statistical analysis

Theresultsofthestatisticalanalysis

arelocatedin Volume No: / Pages:

Ifanyofthedataindicatedpreviouslyarenotprovided,pleaseexplainwhy:

Summary of a bioavailability or bioequivalencestudy(August 2014)

For official use onlyPage 1 of 3