Phase Overview thiab Cov Ntsiab Lus Tseem Ceeb
Kev tshawb fawb ua ntej yog thawj theem ntawm kev tsim tshuaj tshiab, feem ntau kav ntev li 1.5-3.5 xyoo. Nws yog lub sijhawm tseem ceeb rau kev ntsuas kev nyab xeeb, kev ua tau zoo, thiab cov yam ntxwv ntawm cov tshuaj pharmacokinetic ua ntej nkag mus rau tib neeg kev sim. Lub hom phiaj tseem ceeb ntawm theem no yog muab cov ntaub ntawv muaj zog txhawb rau Kev Tshawb Fawb Tshiab Tshuaj (IND) cov ntawv thov los ntawm kev tshawb fawb txog kev sim.
Kev tshawb fawb hauv tsev kho mob feem ntau suav nrog peb yam: kev tshuaj xyuas tshuaj pharmacodynamic thiab tshuaj lom neeg, kev tshawb fawb pharmacokinetic, thiab CMC (tshuaj lom neeg, kev tsim khoom, thiab kev tswj hwm). Hauv kev soj ntsuam tshuaj pharmacodynamic thiab toxicological, cov kws tshawb fawb yuav tsum tau lees paub cov tshuaj ua tau zoo, kev nyab xeeb, thiab koob tshuaj - teb kev sib raug zoo hauv cov qauv tsiaj, tshuaj xyuas cov cim tseem ceeb xws li mob toxicity thiab kev ua me nyuam toxicity. Pharmacokinetic cov kev tshawb fawb tsom rau kev nqus, faib, metabolism, thiab excretion (ADME) cov yam ntxwv ntawm cov tshuaj hauv vivo, muab cov ntaub ntawv pov thawj tseem ceeb rau kev tsim kho cov txheej txheem tom ntej. Kev txhim kho CMC suav nrog cov txheej txheem tseem ceeb xws li cov txheej txheem kev sib txuas ntawm cov khoom siv tshuaj nquag, kev tsim kho, thiab tsim cov qauv zoo.
Hais txog kev cai tswjfwm, kev tshawb fawb ua ntej yuav tsum ua raws li GLP cov qauv thiab ua raws li cov kev cai thoob ntiaj teb xws li 21 CFR Part 58, ICH M3(R2), thiab SEND. Cov txheej txheem no ua kom muaj kev tshawb fawb nruj, kev ntseeg tau, thiab kev tshawb nrhiav cov ntaub ntawv tshawb fawb, ua lub hauv paus tseem ceeb rau cov ntawv thov IND tom ntej.
HyQure BioTech core lag luam nyob rau theem preclinical
HyQure BioTech muab cov kev pabcuam kuaj biosafety thoob plaws hauv theem kev tshawb fawb ua ntej, tsim lub platform kuaj uas yog lub hauv paus ntawm tus kab mob tshem tawm / tsis siv cov txheej txheem validation (VC) thiab cell bank verification (CLC). Ua raws li GLP thiab GMP cov qauv, lub tuam txhab muab cov kev pabcuam kuaj xyuas biosafety rau cov neeg siv khoom thaum lub sijhawm tsim tshuaj thiab kev lag luam, tam sim no suav nrog kev tshem tawm tus kabmob / kev tshawb nrhiav kev ua haujlwm tsis zoo, xovtooj ntawm tes / ntawv pov thawj hauv txhab nyiaj, thiab cov kev pabcuam kuaj cov khoom siv raw.