Cov Ntaub Ntawv Kev Tswj Xyuas Cov Ntaub Ntawv - HyQure Biotech

Technical & Regulatory Documents

Digital Intelligent Healthcare

01

Txoj kev tshawb nrhiav tus kab mob tshem tawm: Kev sib raug zoo rau NMPA / FDA / EMA triple tshaj tawm

Nrog rau kev pom zoo ntawm ICH Q5A (R2) thiab kev hloov pauv tas mus li ntawm kev kuaj xyuas tus kab mob tshem tawm los ntawm cov neeg tswj hwm hauv lub tebchaws, yuav ua li cas thiaj li ua tiav qhov kev lees paub tus kab mob zoo ib yam hauv NMPA, FDA thiab EMA tau dhau los ua ib qho ntawm cov teeb meem tseem ceeb ntsib cov tuam txhab biopharmaceutical thoob ntiaj teb.

02

Tseem ceeb tsim kev txiav txim siab rau Viral Clearance Validation Study Protocols of Gene Therapy Products

Gene therapy cov khoom, raws li ib tug tiam tshiab ntawm biologics, tam sim no cim txawv nyob rau hauv cov kab mob kev nyab xeeb kev ntsuam xyuas piv rau ib txwm recombinant protein cov khoom. Gene therapy vectors (xws li recombinant adeno-cov kab mob sib txuas, AAV) yog lawv tus kheej ntawm tus kab mob.

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