Video: AB rated generic yog dab tsi?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
AB - ntsuas Cov tshuaj yog cov tshuaj uas ua tau raws li cov qauv tsim nyog bioequivalence tsim los ntawm Food and Drug Administration (FDA). Lub tuam txhab kws tshuaj nrhiav kev lag luam a muaj version ntawm cov tshuaj muaj npe tuaj yeem ua Daim Ntawv Thov Kev Siv Tshuaj Tshiab (ANDA) nrog FDA.
Ib yam li ntawd, tib neeg nug, Dab tsi yog A rated generic tshuaj?
A tshuaj cov khoom raug suav tias yog kev kho mob sib npaug ("A" ntsuas ) tsuas yog: a tshuaj Lub tuam txhab daim ntawv thov kev pom zoo muaj cov pov thawj scientific txaus tsim los ntawm hauv vivo thiab / lossis hauv vitro kev tshawb fawb txog bioequivalence ntawm cov khoom mus rau ib qho kev xaiv siv tau teev tseg. tshuaj.
Ib yam li ntawd, qhov txawv ntawm kev tso cai generic thiab generic yog dab tsi? Ib Tso cai Generic yog lub tuam txhab lag luam cov khoom lag luam rov ntim thiab ua lag luam raws li ib muaj tshuaj los ntawm ib tug neeg ua hauj lwm los yog ib tug thib peb tog. Ib Tso cai Generic yog ib hom tshuaj muaj npe - twb tau pom zoo raws li Daim Ntawv Thov Tshuaj Tshiab (NDA) los ntawm FDA - thiab ua lag luam raws li muaj khoom nyob rau hauv ib daim ntawv lo.
Ua kom pom qhov no, qhov txawv ntawm ab1 thiab ab2 yog dab tsi?
Yog li, yog tias cov khoom lag luam muaj npe raug ntsuas " AB 1 "tsuas yog generics uas raug ntsuas" AB 1 ” raug suav hais tias kho tau zoo ib yam li cov khoom lag luam. Ib yam li ntawd, yog tias lwm yam khoom muaj npe raug ntsuas " AB 2 ", kev kho mob sib npaug generics yuav raug ntsuas" AB 2 ”.
Dab tsi yog qhov ntsuas AB hauv Orange Book?
(2) qhov tseeb lossis muaj peev xwm bioequivalence teeb meem tau raug daws nrog qhov tsim nyog hauv vivo thiab / lossis hauv vitro pov thawj txhawb bioequivalence. Cov no raug xaiv AB . cov khoom siv tshuaj rau qhov tseeb lossis qhov muaj peev xwm bioequivalence teeb meem tsis tau daws los ntawm cov pov thawj txaus ntawm bioequivalence.
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