甲唑凝胶生物等效性体外研究.pdfVIP

ActiveIngredient:Metronidazole

DosageForm;Route:Gel;topical

RecommendedStudies:Twooptions:invitroorinvivostudy

1.Invitrooption:

Toqualifyfortheinvitrooptiontodemonstratebioequivalenceformetronidazoletopicalgel,

1%thefollowingcriteriashouldbemet:

A.Thetestproductshouldcontainnodifferenceininactiveingredientsorinotheraspectsofthe

formulationrelativetothereferenceproductinthesamepackagingconfiguration(tubeor

pump)thatmaysignificantlyaffectthelocalorsystemicavailabilityoftheactiveingredient.

Forexample,ifthetestandreferenceproductsarequalitatively(Q1)andquantitatively(Q2)

thesame,asdefinedintheGuidanceforIndustryANDASubmissions–Refuse-to-Receive

1

Standards,thebioequivalenceofthetestproductwithrespecttothereferenceproductmay

beestablishedusingtheinvitrooptionifthecriteriabelowarealsosatisfied.

B.Thetestandreferenceproductsinthesamepackagingconfiguration(tubeorpump)should

bephysicallyandstructurallysimilarbaseduponanacceptablecomparativephysicochemical

characterizationofaminimumofthreebatchesofthetestandthreebatches(asavailable)of

thereferenceproduct.Thecharacterizationofthetestandreferenceproductsshouldinclude

thefollowingcomparisonsofphysicalandstructuralattributesweenthetestandreference

products:

i.Assessmentofvisualappearancewithrepresentativemicroscopicimagesatmultiple

magnifications.

ii.Analysisoftherheologicalbehaviorwhichmaybecharacterizedusingarheometerthat

isappropriateform