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fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms

1997; Volume: 4; Issue: 4 Linguagem: Inglês

10.14227/dt040497p15

2376-869X

Vinod P. Shah, Lawrence J. Lesko, Jim Fan, Nicholas M. Fleischer, James Handerson, Henry Malinowski, Moheb H. Makary, Larry Ouderkirk, Suva Roy, Pradeep Sathe, Gur Jai Pal Singh, Lloyd Tillman, Yi Tsong, Roger Williams,

Drug Solubulity and Delivery Systems

Dissolution Testing of Immediate Release Solid Oral Dosage forms 7iJis gllidl/I/ce is df'lleloped jar immedil/Ie "lease (lR) dosl/ge j017I1S I/Ild is illtrnded 10 prrruide (/) gel/eml 1'(!r0711111/!Iftintiol1S for dissolmiol1 testing; (2) approaches for settillg tlisso/lllion specifications feinted to the hiop/Jfl17mlccllfic rvn11lcterist;rs oftbe drug substallce; (3) stnlisriclI/1I1efbods for comparing disso/llfioll profiles; ({ud (J) (/ prOCeII' to belp determine when din"olution testing is SfljJide1lt to grant (J woiver for 011 ill vivo bim:qllit'lllcl1ct!st/ld).This t/ocumf!11f "Iso p1TJvides recommendations for dissolutiol1 tests to be/p eJlSflrc c011till-IIOliS drug prodfll1 fjllflliry IIl1d pnfo17JlfUlCe ofter m1ni1l portuppITJVol1ll0nllfnctliring chonges.SU1II1I10ry il/fort/wlio" 01/ dissoillt iOlllllt'fbodology) IPP"ratlls) IIlId operllting conditiollS for dissolution testing of I R pmd-lIffS is provided ill SIlIllIllIll)1 forlll ill Appelldix A. Tbis guidonce is ime1lded to comple1llelll tbe SUPAC -I R gl/idnllce jar il/ill/slly: 1III111eililllr RelellS" Solid 01'111 Dosage FOl7l1s: Scilie-llp nlld Post-Appmvnl Challges: Cbe1llistly, {\fulIlIjiltturiJlg IIlId COIlf1¥J/S, In Vitro Disso/llfiol1 Testing, IIlld 111 VIVO Bioequiullience Dommen/alio/1, 11 1 i//; jpeciji( IY'ji'l"f!Jl(e to the gel1f!f{lIioll of disso/mioll profiles for CfJwpllmtive pmposes, ' Vorking Group Members: 'Tb(l' IIIJ/(;IfiIIIl/s OflTTrntJy HI u:ttb lIN FDA 'Th,s gllidn"rr hIlS bUll prtparrd by fht Immtdi.a/tRdfllst &''f!C1•t WorkiNg Group oftht BiophonNoctuti($ Cf)()rtlil1lJrillg C"mmltttt In tht Cmu,.for Ot'lIg eVlJllIIllirm and Rtstllrch (COER) lit the Food 11111/ Drug Ad",i/l;Strllt101l.This guitumu document l"fprtmm tht Agrngr OIrTnlf thillking Oil the dISsolution tmlllg of "",ntdiate nlellst sQ/ill uml dosRgt fflnns.It dots I/ot CI"tIlIC or (/Jllfn• lilly rights for (»"" 011 fmy perso" (md d()t$ lIot opn-ntt to himl FDA or tht public.All Illttrndriw approach mllJ ht lIstd If SItCh ftppronch JarisjitJ fbt nqllirnlll'lIIs of tbr