analysis of genotoxic impurities：基因毒性杂质的分析

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1、ChairmanDatePageAndrewTeasdale,AstraZeneca23February20064/4ChairmanDatePageAndrewTeasdale,AstraZeneca23February20061/4ParticipantsSecretaryRichardDennis(GSK),GarethPearce(MSD)PeteYehl(MSD),AndrewLipczynski(Pfizer)KarenTaylor-Worth(Pfizer),PaulRavenscroft(GSK)ChrisHinds(Sanofi-Aventis),SimonHicks(

2、GSK)ElizabethSwain(AZ)MeetingdateLocation23February2006AstraZeneca,CharnwoodSubjectReferencePASGSubGroup–AnalysisofGenotoxicImpuritiesPASGSubGroup–AnalysisofGenotoxicImpurities1.Roleofsub-groupItwasagreedthatthegroupshouldfocuseffortsaroundthefollowingpoints:oTogainageneralconsensusonwhat‘ALARP’(

3、aslowasreasonablypracticable)means,frombothananalyticalchemistryandprocesschemistryperspective.Itwasalsorecognisedthatthiswouldvarytechniquetotechniqueandbeinfluencedbytheanalyte/matrixcombination.oTosharebestpracticeintermsofrobustanalyticalmethodologyandtoconsidertheappropriateuseofgenericmetho

4、dology,especiallyforspecificclassesofgenotoxicimpurities,e.g.alkylsulphonates.oUnderstandandagreehow‘StagedTTC’conceptsaretobeapplied.(TTC:ThresholdofToxicologicalConcern)andthiswillimpactuponanalyticalchemistryintermsofLODsandthetechniquesapplied..oDevelopmentofspecificationsforgenotoxicimpuriti

5、es.oUnderstandregulatoryrequirementsbysharing,wherepossible,experiencegainedfromclinicalsubmissions.Influenceregulatorycolleaguesinternallyanddefineappropriatelevelsofdisclosureduringdrugdevelopment.oBestpracticerelatingtothereductionoflevelsofgenotoxicimpuritiesviaprocesschemistrymechanisms.oTos

6、harebestpracticeandinfluenceexternalbodiesviapublications(discussedinmoredetaillaterinthesenotes).oTokeepawatchingbriefoveremergingtoxicologicalinformationonthistopic.Action:ATtosharewiththegroupinformationrelatingtotheproposedcollaborationwithPQRI(PQRIWebsite).ChairmanDatePageAndrewTeasdale,Astr

7、aZeneca23February20064/4Itwasacknowledgedinthemeetingthatthereareseveralissuesregardingthesharingofinformationonthistopicgivenfactorssuchasproprietaryinformation,competitiveadvantage,intellectualpropertyetc.However,itw