Pooled dissolution testing : A primer

Q4 Pharmacology, Toxicology and Pharmaceutics Pharmaceutical technology Pub Date : 1997-01-01 DOI:10.14227/DT050198P15

Royal Hanson, Michael E. Swartz, R. Jarnutowski

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引用次数: 0

Abstract

f)J: I,ee T Gml(V of US' I) btls pro/lww/ (I 1J('71' !"bor-.I'{fi.l;J1P,' /lie/bod jiJl" disJollltioll lestillg. Tbe propo,wd clfl/.'ji;r 1t'.Ilillp.: ~r poo/cd SlIwp/e.r, fbcrd~)I reducillg tbe {/1111~)lfi((l1 ",,}"dcII. J/Ji.l' art ide n'7. 'it'7.1',1" Ibe prilloiJie.f bebilld fbI' US'P propo,wtl. {/.1 'iN/! liS 171'0 prflt/icrt/ Jl/l'lbotlrJor {fcbievillg poolcd di.I".I-u/lllioll feslillp;. .field oIdh)'olutioJl fest illg. For Ibe pr.ft lime ill 25 ye(ll:l', (I fill1dmll(,l1/(ll p(lmdigfll .I'/;ij1 is heillg ulji"w/ ill (lfl ("'If~ylirtll ta/;lIifJue ({lId il provir/('s 1101/01' fill illl'rM,fl'. bUf II redllctioll of fbt' mrrml diy.;solmioll n'or/.: IOfld,A! its first level, poolcd dissoIfflioll reI(,I), to ({.\)'(~yillg II pooled sfllJlplcj;WII illdividlllli dissoImioll /.'('.11'('/s, simplij)lillg Ibc mrrellf /(I.\'k 0/1I11111iple (1II11~yses )i'OIll illdit'id(llli VC .... fl'/s, IlIId IbllS providing some relitf to Ibe '1II1I~)lti({f1 hllrdcn. /Ll t its ,I'uo"d ICi'l'I, pooled di.l:wllltiolJ refers 10 Ibl! Il'.fling o/lIIlIltiple IIlIits ill II singh' iH!SS(,I. t1(birvillg j,ti/! grl'll/cr 7.:·ork 10lld sirvillg:fjur Ibe 1II0dcrll dissolmioll IlIb, II is "lm .Wf'!{f!;c.I'ted tblll II 1lC7l l llp/,lIrttlll.l'jor feslillg IJ/ultiple IIllits in II singl(' vf.lTl'1 fllfI)' hl' (oJI.I'idl'I'i'd. '/'bis IIrlide provides 1111 OVl'/7.'il'7!' oIlb£' lll'7f USP proposIII. fllollg wilb 17.1'0 pmrfiml IIIl'lbot/xIar pooled dissolulioJl Il'.rtiJlg Iblll flrc IIlIflil/flb/e witb cOIJ/Jllcrcill1 e(/lIipIII£'1I1 m:(fil"b/e totl,,)', tl'l' 7: Grtu{V. director of/he Drllg S',,,"t/ffrd,,' Djzli.rioll o/Ibi' Ulli/cd S'/tl/l'S Pbllrlllllcopeifl (USP), blls propo.fcd II /Ie'i.i' (Oll((,/,' ill tlJe field ofdij)'olutioll testillg: pookd fH,'JO/lllioll (J). A h~v prill{iplt· ill fbir proposlIl is fbe "b"lr/; c/JlI/'(f(/cri.\'fi(" ofdi,\'.\'ollllion Intillg, IIlId II primlllY bene}if is tb(, "redll(lioll o/Ibi' (/J/(/~yliml burr/clI, ,. U.\'P blls dl7110llslmlcd ilSelf fo b(' (/ jiu7:'flrdlookillg. 1L·orld-dIlS.r OIgllJlizlltioll l~)' 11I/':illJ!, Ib(' Imd iJl such flrf!({S /1,1' fbe inferJl/ltiollll1 b(lI"IIIOlli::"fltioll ofsfflJldanh IIml Ibe elll!irOIllJll'1!1111 iJllparl o/flloderlll/JIfl~yti(l" rrlll/in'mel/lSjiJr rmgellls (2), ,)'ip.:"ij;mll/~y, Ibis 1Il'71' proposlIl is bi.\'torh ill 1/.1('

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集合溶出试验:引物

f)J:我，我看到了T Gml(V of US' I) btl pro/lww/ (I) 1J('71' !"bor- I'{I . 1;J1P，' /lie/bod jjl " disJollltioll ' still。这个提议，他会说:“我不知道，我不知道。”: ~r poo/cd SlIwp/e。r, fbcrd~)I减少{/1111~)lfi((l1 "，，}"dcII。J /霁。我在2007年出生。'它'7.1'，1 ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '如果联邦调查局(fbI)的美国法律提案不成立，那么。{/。/ 1 ' !“i’’’”“i’’”“i’’”“i’’”“i’’”“i’’”“i’’”“i’’”我的意思是我的意思是我的意思是我的意思是我的意思是我的意思是我的意思。Ibe pr.ft石灰生病25你们(我l’,(我fill1dmll (l1 / (ll p (lmdigfll。我的/;ij1 heillg ulji“w /生病(lfl(“如果~ ylirtll ta /; lIifJue({盖子il provir /(1101/01的“填补illl且,fl”。但我对我的工作充满了兴趣。: IOfld !它的第一层，poolcd dissoifflill reI(，I)，到({.\)'(~yillg II pooled sfllJlplcj;WII illillillilli dissoiffoll /.'('. ')。11'('/ ' s, simplij) ' '('/s, simplij) ' ';\'k 0/1I11111iple (1i11 ~yses)i' ill ' dit'id(lli VC ..../年代fl, IlIId IbllS提供一些relitf Ibe的1 ii1i ~) lti ({f1 hllrdcn。/好吧，我来，我来，我来，我来。1: willtiolj指的是10磅!Il’。【翻译】【翻译】【翻译】【翻译】【翻译】【翻译】t1 (birvillg j, ti / !grl / cr 7。·工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作/工作我想要我的小宝贝，小宝贝。i ' major fillils / multiple illits in II single (i ' vf)。lTl 1 fllfI)的hl”(oJI.I 'idl份子份子。'/'bis IIrlide提供1111ovl '/7.'il'7!美国药典提案(USP proposal ii):液体将会是17.1'0 pm，液体将会是/ /混合溶解液体。rtiJlg Iblll flrc IIlIflil / flb / e witb cOIJ / Jllcrcill1 e (/ lIipIII£1 i1 m: (fil”b / e totl,), tl孩子7:Grtu {V。“……”“……”“……”“……”riolll o/Ibi' Ulli/cd 'S /tl/l'S pllllllll_copeifl (USP)， bll提案。fcd II /是的。i' (Oll((，/，' ill tlJe field ofdij)' ' oltill testling: poolkd of h，'JO/ oltill (J). A h~v prill{iplt·oltill proir proll ' l是' b ' ' lr/;c / JlI / (f(/中国国际广播电台。(“对外直接投资,\ ' \ '。\ ' ollllion Intillg IIlId二世primlllY野猪}如果是结核病(“redll (lioll o / Ibi”(/ J / (/ ~ yliml毛刺/ clI,,。u ' 'P ' s blls dl7110 ' ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll ll;1 l·orld-dIlS。/ / / / / / / / / / / / / / /我想要这样的礼物!{S /1,1' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '1111 iJllparl o / flloderlll / JIfl ~ yti (l”rrlll / 'mel / lSjiJr rmgellls(2),,)的ip。:“ij; mll / ~ y,宜必思1 il 71”proposlIl bi。\'火把1/ 1('

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