Dab tsi yog qhov khoom pov thawj?
Dab tsi yog qhov khoom pov thawj?

Video: Dab tsi yog qhov khoom pov thawj?

Video: Dab tsi yog qhov khoom pov thawj?
Video: Maiv Xis Xyooj Khaus Pim | Tub Siab Loj Xa Lus Rau Maiv Xis Xyooj 2024, Kaum ib hlis
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Muab pov tseg batch yog ib qho uas tuaj yeem tsim tawm hauv cov chaw tsim khoom lossis txawm tias hauv cov chaw tsim khoom cog uas muaj cov cuab yeej zoo sib xws xws li hauv cov chaw tsim khoom. Ib nthuav tawm batch tseem hu ua LATE PILOT QHOV TSEEB uas yog siv los muab cov ntaub ntawv ruaj khov loj raws li ICH cov lus qhia xa rau daim ntawv thov ANDA.

Tom qab ntawd, ib tug kuj yuav nug, dab tsi yog validation batch?

Validation batch yog coj mus muag scale pawg uas yog manufactured consecutively nyob rau hauv thiaj li yuav siv tau txheej txheem raws li a kev lees paub raws tu qauv uas tau tsim thiab tso cai.

pilot batch yog dab tsi? Pilot Batch txhais tau tias a pawg ntawm cov khoom tsim thaum lub sij hawm txoj kev loj hlob ntawm ib lub ntim txaus rau cov txheej txheem kev txhim kho, kev ntsuam xyuas kev ruaj ntseg thiab muaj feem xyuam rau cov kev ntsuam xyuas zoo tsim nyog yuav tsum tau los ntawm Development Program, siv excipients tsim nyog cia siab tias yuav tsum tau soj ntsuam kev nyab xeeb thiab muaj nyob rau hauv ntim

Ib yam li ntawd, ntau npaum li cas cov khoom pov thawj xav tau rau ANDA xa?

peb

Dab tsi yog bio batch?

Biobatch tseem hu ua Bio kev soj ntsuam xyuas pawg uas yog npaj rau kev sim tshuaj hauv NDA lossis ANDA daim ntawv thov. Cov kev tshawb fawb bioequivalence ib txwm yuav tsum tau ua rau txhua yam khoom lag luam tshiab hauv cov khoom lag luam uas tau sim tawm tsam tus neeg tsim khoom lag luam cov khoom lag luam 4-5.

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