Muaj pes tsawg qhov khoom pov thawj xav tau rau ANDA xa?
Muaj pes tsawg qhov khoom pov thawj xav tau rau ANDA xa?

Video: Muaj pes tsawg qhov khoom pov thawj xav tau rau ANDA xa?

Video: Muaj pes tsawg qhov khoom pov thawj xav tau rau ANDA xa?
Video: PES 2021 КАРЬЕРА "ХАРДКОР" #2 2024, Kaum ib hlis
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A6: Raws li FDA cov lus qhia ruaj khov, tus neeg thov yuav tsum xa cov ntaub ntawv los ntawm peb pawg ntsuas dav dav lossis yuav tsum xa cov ntaub ntawv los ntawm ob qhov kev ntsuas dav dav thiab ib pawg me me. Qhov no siv tau rau txhua daim ntawv siv tshuaj.

Ntawm no, cov khoom pov thawj yog dab tsi?

Tso tawm ntau pawg txhais tau tias kev tsim khoom pawg ntawm Cov Khoom Muaj Ntawv Tso Cai xav tau los ntawm FDA txhawm rau ua daim ntawv ANDA rau Cov Khoom Muaj Ntawv Tso Cai.

Ib yam nkaus, dab tsi yog kev lag luam hauv cov tshuaj? Zaub pawg 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 qho khoom pov thawj pawg 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.

Cov lus nug tseem yog, cov npe rau npe yog dab tsi?

Cov Npe Sau Npe txhais tau tias pawg los yog pawg ntawm cov tshuaj Atamestane thiab/lossis cov khoom lag luam tshuaj ua hauv GMP cov xwm txheej uas yog lossis tsim nyog los txhawb kev ua daim ntawv thov kev lag luam lossis daim ntawv thov tshuaj tshiab rau Cov Khoom Muaj Ntawv Tso Cai.

Kev ruaj ntseg raws tu qauv yog dab tsi?

Kev ruaj ntseg raws tu qauv . • Xav tau a raws tu qauv los pib ruaj khov cov ntaub ntawv teev tseg: - Txheeb xyuas cov xwm txheej, kev qhia tshwj xeeb, txoj hauv kev sim, ntsuas zaus; - Hnub tsim khoom thiab hnub pom zoo. - Lub sij hawm xoom cov txiaj ntsig (piv txwv li ntau cov ntaub ntawv tso tawm)

Pom zoo: