Nonclinical (SEND) Fit for Use Workstream

Transcription

1 Ncliicl (END) Fi f Us Wm Th CDIC END ( f Exchg f Ncliicl D) m, i cllbi wih h PhUE Ncliicl Ts bmissis Wg h FDA CDER Offic f Cmil cic (OC), cc wm f ilig END V3.0 h ws h blic ici. Picis (cliicl sbmiig gizis, sss hi lgs) hv ccl sbmiig, civig il fbc, mi c livbls b sh bl his wii si, which is ll (i, blicl ccssibl). O f h mi s f h Fi f Us Pil ws h fbc vi bc ch ici wl b sh wih h blic bl, vi h CDIC PhUE gizis wig csss. Lig fm his il is big s ifm is CDIC PhUE m ffs. Ths ms ll wh is i ss imlmi Lig hs ls b ic i vsi 3.3 f h D Tchicl Cfmc Gi. T m h mi f "sh lig", h fllwig livbls vilbl blw: Psis (i.f fm): CDIC-PhUE Fi f Us Pil, Ocb 2016 END Chllgs, Tbl Exmls fm Fi f Us, Ocb 2016 INDUTRY FEEDBACK, Mch 2017 INDUTRY FEEDBACK: Dmi / D Fil Lvl Lig,

2 Acl Fbc fils (i zi fils b xc): Ifmil cgs h icl h cl (c) fbc fm h FDA iivil ss icis, Ail 201

3 Pil Ch, iiii:

4 This is blic-fcig wii si f shig lsss l fm h "Fi f Us" END Pil scib i h ch ch, vsi 1.0: Th Fi f Us Pil W m Ch v cx. Pil C, Cvg f h il liv END s v3. 0*: R w # T ( i g l, R, C c) G L P / G L P? W s h T m. x sb mi (i ii TF mi f E ND)? W s h D R G & D fi fil s b mi? W s h f f h s b m i? ci D i M l i l T m s F q c Dmis icl Hsig f imls s Dsig cmms Dscib h ws c i END fm Ws h cl / mm m s/ vi is fil icl i il sbm issi? Aiil cmms vi 1 R Ds GLP N Ys Ys m 4- w wih c v 2 R Ds GLP N Ys Ys g 1- m h wih c v 3 R Ds GLP N Ys Ys 4- w 4 R Ds GLP N/A Ys Ys g 4- w wih 4- w c v 5 R GLP N Ys Ys 3- M Ds h sb c s si g BW, EX, BG, PC, PP, EG, LB, RELREC, CO, CL, DM, D, MA, MI, OM, TE TA, T, TX,. BW, CL, CO, DM, D, EG, EX, LB, MA, MI, OM, PC, PP, RELREC, C, E, UPPCL, UPPEX, TA, TE, T, TX, V QD TE, T, CO, DM, E, TA, TX, EX, D, BG, BW, CL, FW, LB, MA, MI, OM, PC, UPPMA, UPPMI ll vi gv g, c QD, l BG, BW, CL, CO, DM, D, EG, EX, LB, MA, MI, OM, PC, PP, RELREC, E, UPPBG, UPPBW, UPPCL, UPPD, UPPLB, UPPMA, UPPMI, UPPTF, TA, TE, TF, T, TX BG, BW, CL, CO, DM, D, EX, FW, LB, MA, MI, OM, PC, PM, POOLDEF, PP, RELREC, UPPBG, UPPBW, g sigl hs sigl s i chg f sm imls, sigl sli, mi s imls ls sv s imls Dsig mi cs; slli imls; sigl sli. sig ws cms f 5 gs wih 10/sx/g i h mi s 6 slli imls /sx/g f TK. Dsig i h 600 mg/g (high-s) g isci Ds 11 6, scivl i mls fml s. Ths imls w ci s wih fh sig. ADA W sli i bl s lsis i END h ws i h s, b hig i h s ws missig i END. fil icl Fll s wih cl mm s, vii s, c ws icl g Fll s icl g lli gs s f TK, l smls. Fll s icl iil cmms W cll sbmi 4 sis cc h sm cm h il. O ws fll viw, h h hs w chc f fiss. Tw sis sbmi, viw i fll, 90- g ws chc f fiss l.

5 6 R Ds 7 R Ds 8 R Ds 9 R Ds 10 R Ds 11 C ci gi ci 12 R Ds 13 R Ds N GLP N Ys N m 28- wih 28- c v i N Ys Ys ml 7 GLP NA Ys Ys g 4- w c v - GLP - GLP N N D RG vi Ys g 28- D wih 28- D c v i N Ys Ys g 14- D N Ys Ys sg ic m s N Ys Ys C m lg s M s 26- W 4 w N Ys Ys R 3 w IV slw bls UPPCL, UPPD, UPPFW, UPPLB, UPPMA, UPPMI, UPPPM, UPPTF, TA, TE, TF, T, TX T,TE,TA,TX,CO,DM,E, EX,D,BW,BG,CL,LB,MA, MI,OM,PC,PP,V,EG, RELREC, UPPMA, UPPMI, UPPCL, UPPPC, UPPLB Ol BG,BW, CL, DM, D, EX, LB, MA, MI, PC, PP, E UPPBG, UPPBW, UPPCL, UPPD, UPPLB, UPPMI, TA, TE, T, TX Ol (gv g) si g Ol Gv g si g Ol gv g si g BG, BW,CL, CO,DM, D, EG, EX,FW, LB,MA, MI, OM, PC, POOLDEF,PP, RELREC, E, UPPMA, UPPMI, TA TE, T, TX, BG, BW, CL, CO, DM, D, EX, FW, LB, MA, MI, OM, PC, PP, RELREC, E, UPPCL, UPPMA, UPPMI, TA, TE, T, TX, V BG,BW,CL,CO,DM,D, EX,LB,MA,MI, PC,PP,RELREC,E, UPPBG,UPPBW, UPPCL,UPPD, UPPMA,UPPMI, UPPV,TA,TE,T,TX,V Ol BW,CL,CO,DD,DM,D, EX,FW,LB,MA,MI, gv RELREC,E,UPPCL, g UPPMA, UPPMI,UPPTF,TA,TE, TF,T,TX si g 2 s s, h w 2 s ic ls s c w l f 3 w TA, TE, T, TX, CO, DM, E, EX, D, BW, BG, CL, LB, MA, MI, OM, PC, PP, UPPBG, UPPBW, UPPCL, UPPD, UPPLB, UPPMA UPPMI BG, BW, CL, CO, DM, D, EX, LB, MA, MI, OM, PC, PP, RELREC, E, UPPLCL, UPPMA, UPPMI, TA, TE, T, TX cill-hs, ml l MICRONUCLEU Ass, PBMC (Pihl bl mcl cll lsis) ssssm, PP mi icl iivil vls whil h s l hs h ms clcl fm hs iivil vls. G Dg/Bgl, igl sli, mi s imls ls f TK 24 s (3/sx/g) NA N vi Pcl, iil Amm cmms s, Dviis fil icl: Pcl icl. Th w viis mm s. N - Fil sig. R l (which ss h fil mhlg) G xc ig fig, mls l ECG Pcl icl: Pcl mm s f h PDF sbmi DRG sbmi vsigh G fmls l Fll s wih cl mm s, vii s, c. ws icl 3 s cg Tx m: G 1 (cl), 2, 3, 6 Th iml ms w mii TK m: G 4, 5, 7 m bw gs Fhhi, liv hmii bw 20 80%. Th m hmii w c hgh h s b mic miig ssm. Th ligh/ ccl i h ms ws 14 hs f ligh, sig 5:30 m, fllw b 10 hs f s. Th vili ssm s miimm f 15 i chgs h. Uilsis w c il ssm limiis, which big ss i Wh siizig h ss ws ic i h PC mi. I h PC mi, PCTPTNUM=0. 17 i h igil s lc wih PCTPTNUM=0 i h siz s. *Th cs f his bl w vi v l i h il ff ms h m cvg f vi i h il; iivil w(s) s cssil lig wih h fbc s his si. Pls vi cmms hv gig his wii si blw.

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