美国FDA关于合成多肽的指导原则

FDA(,100050)[];;[]R927[]C[]1003-3734(2001)08-0626-032070,HPLC,,(NMR)(MS),,,,(MAPs),(CBER),(IND)(NDA)(ANDA)(PLA)(DMF)(BMF),11.1:(pI)(),,1.2/:,,EdmanN,Edman,NC,,,,20,(20),()(),,,,(Ellmans)2,()CBER,,22.12.1.1,,,TLCHPLC626ChineseJournalofNewDrugs2001,Vol.10No.82001108,,,,,TLC/HPLC2.1.2,:()()()2.1.32.22.2.1,2.2.2,N((t2Boc))2.32.3.1,(),,,2.3.2,,1:(),,t2Boc,Fmoc,/2.3.3N2,2.42.4.1:()()/2.4.2,,,,,2.4.3,,,()(),33.1:TLC::EllmanHPLC3.2,726ChineseJournalofNewDrugs2001,Vol.10No.82001108,TLC/HPLC3.33.4,4,/,(lotreleasespecifica2tions):(),/,,pI,,,HPLC,,,HPLC(CZE)(PAGE),,lvEdmanEd2man,lwlxlyD2,lz20,l{,5,,/()()(),,6,(),,,7,,-20,,,,,[](1966-),,,,:[phone]-231(:2001-03-22:2001-05-11)826ChineseJournalofNewDrugs2001,Vol.10No.82001108