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

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, { IIlId COIlf1J/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/t Rdfllst &''f!C1t 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