新药基因毒性杂质风险分析Risk assessment of genoto(7)

(5)Muller,L.;Mauthe,R.J.;Riley,C.M.;Andino,M.M.;Antonis,D.Fagerland,D.;Beels,J.A.;C.;Frank,DeGeorge,R.;Frischel,J.;DeKnaep,B.;Galloway,A.G.M.;S.;Ellison,Harpur,D.;E.;Humfrey,OC.D.;Jacks,A.S.;Mackinnon,J.;Mohan,

Toxicol.’Donnovan,Pharmacol.M.R.;2006Smith,,44,M.198 D.;211.Vudathala,G.;G.;Yotil,Ness,L.D.Regul.K.;Toxicol.(6)Bos,Lett.P.2004M.J.;,151Baars,,43.B.;Marcel,T.M.;vanRaaij,M.T.M.

(7)Ashby,J.;Tennant,R.

the(8)LimitsEMEA/CHMP,ofGenotoxicQuestionsW.

ImpuritiesandMutat.

,EMEA/CHMP/SWP/431994;AnswersRes.on1991the,CHMP257,229Guideline 306.

2007.on

Carcinogenic(9)FDA,CenterforDrugEvaluationand

Approaches(Draft)Impurities;2008.inDrugSubstancesandResearch.Products:GenotoxicRecommendedand

(10)(11)PhRMAInternationalSurveyConference;pendingpublication.onHarmonisation(ICH).GuidelineQ8(R2):NoteForGuidanceOn

Q9:(12)QualityInternationalRiskManagementConference;2009.onPharmaceuticalHarmonisationDevelopment(ICH).,Guideline2009.Biomed.(13)Liu,2009D.,Q.;50,Chen,144 150.T.K.;McGuire,M.A.;Kord,ASJ.Pharm.Camurri,(14)Cimarosti,Z.;Bravo,F.;Stonestreet,P.;Tinazzi,F.;Vecchi,O.;

(15)Teasdale,.A.;ProcessEyley,Res.S.C.;Dev.Delaney,2010,14E.;(4),Jacq,993K.; 998.Taylor-Worth,K.;SchulteLipczynski,Oestrich,A.;R.;Reif,Sandra,V.;Elder,S.;David,D.P.;.Facchine,ProcessK.Res.L.;Dev.Golec,2009S.;,13,429

K.;(16)Lipczynski,Teasdale,433.

A.;A.;Hoffmanan,Delaney,E.;W.;Eyley,Reif,S.V.;C.;Elder,Jacq,D.K.;P.;Taylor-Worth,Facchine,K.L.;Res.Golec,Dev.2010S.;Schulte,14,999Oestrich, 1007.R.;Sandra,S.;David,.Process

Regul.(17)

(18)Toxicol.Dobo,K.

Pierson,Pharmacol.L.;Greene,

D.A.;Olsen,2006N.;

B.,44Cyr,

A.;,282M.

Robbins, 293.O.;Caron,S.;Ku,W.W.

D.K.;DeVries,K.M.;Varie,

Process(19)D.Teasdale,.

Res.Dev.2010A.;ProcessFenner,Res.Dev.

,14,943S.; 945.Ray,2009A.;,13Ford,,285 A.;291.Philips,.

of(20)GenotoxicTeasdale,ImpurityA.;Elder,Risk.D.;Fenner,InGenotoxicS.StrategiesImpurities:fortheStrategiesEvaluationforIdentiChapter cationandControl;Teasdale,A.,Ed.;Wiley:NewYork,2011;

(21)Bankston,9.D.;Dumas,J.;Natero,R.;Riedl,B.;Monahan,M.-K.;Sibley,(22)Bretherick,.ProcessL,ThionylRes.Dev.Chloride2002,(Sulphinyl6,777 781.Chloride)monograph,HazardsChemistry:intheChemicalLaboratory

(23)Stegmann,London,S.;Levellier,1981:pp,3rded.;RoyalSocietyof

F.;503Franchi, 504.D.Eur.J.Pharm.Sci.2007,31(24),249Lee, 261.C.;Helmy,R.;Strulson,C.;Plewa,J.;Kolodziej,E.;Antonucci,Res.V.;Mao,B.;Welch,C.;Ge,Z.;Al-Sayah,M.A.

(25)Dev.Personal2010,14communication:,1021 1026,DOI:Org.Process

James10.1021/op1000397.Harvey(GSK).(26)Thea,S.;Cevasco,.Chem.1988,53,4121 4122.