Lub ntsiab lus ntawm pilot batch yog dab tsi?
Lub ntsiab lus ntawm pilot batch yog dab tsi?

Video: Lub ntsiab lus ntawm pilot batch yog dab tsi?

Video: Lub ntsiab lus ntawm pilot batch yog dab tsi?
Video: lub tuam tsev no instrumental by all stars inspirational 2024, Kaum ib hlis
Anonim

Pilot Batch txhais tau tias ib 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

Tsis tas li ntawd, dab tsi yog pilot batch Pharma?

A pilot batch yog ib qho uas feem ntau yog siv rau scale-up thiab optimization kev tshawb fawb. Koj tsis tuaj yeem nqa EXHIBIT BATCH mus txog rau ( tus tsav ) Scale-up pawg yog tiav lawm. Tsis muaj leej twg muaj peev xwm them taus txoj kev kawm Stability hauv Kev Lag Luam pawg raws li nws muaj lub sijhawm ntev thiab nws cov khoom yuav raug nkim.

pilot manufacturing yog dab tsi? Pilot manufacturing yog cov txheej txheem rau cov khoom siv uas yuav raug kuaj hauv kev sim tshuaj lossis tus tsav kev lag luam ua ntej hloov mus rau tag nrho ntau lawm.

Hauv qhov no, dab tsi yog pilot bio batch?

yog ib qho zoo tshaj plaws software uas kwv yees qhov nqus. cov qauv, pharmacokinetics, thiab pharmacodynamics rau cov tshuaj siv los ntawm cov hlab ntsha, qhov ncauj, ocular, thiab pulmonary txoj hauv tib neeg thiab preclinical hom thiab yuav dhau los ua lwm txoj hauv kev rau Bio kev kawm.

Vim li cas koj thiaj xav tau 3 batch rau validation?

Hauv txheej txheem kev lees paub , pib peb pawg raug muab rau kev lees paub . Tus naj npawb ntawm pawg yuav tsum tau nyob rau hauv kev lees paub nyob ntawm qhov kev pheej hmoo koom nrog hauv cov txheej txheem ntawm kev tsim khoom. Qhov kev paub tsawg dua ntawm cov txheej txheem yuav tsum muaj cov ntaub ntawv txheeb xyuas ntau dua kom paub meej tias qhov ua tau zoo ib yam.

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