Video: ICH stability test yog dab tsi?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Sib sau ua tshuaj kev ntsuam xyuas kev ruaj ntseg cov ntaub ntawv ntawm cov khoom siv tshuaj lossis tshuaj yeeb tshuaj los txiav txim siab tag nrho ruaj khov profile yog ib kauj ruam tsim nyog hauv cov txheej txheem kev pom zoo tshuaj. Cov khoom siv tshuaj, cov khoom siv tshuaj, cov khoom siv sib xyaw ua ke, thiab cov khoom siv raw yuav tsum raug ntsuas rau ruaj khov.
Hauv qhov no, qhov kev ntsuam xyuas kev ruaj ntseg yog dab tsi?
Kev kuaj kev ruaj ntseg yog ib txoj hauv kev los xyuas qhov zoo thiab yuav ua li cas lub kaw lus lossis software coj tus cwj pwm ntawm ib puag ncig tsis zoo xws li qhov kub, qhov hluav taws xob thiab lwm yam. Nyob rau hauv kev lag luam, cov khoom lag luam khaws nws cov khoom zoo li cas rau lub neej ntev ntawm cov khoom.
Tsis tas li ntawd, cov txheej txheem zoo li cas raws li ICH? Daim ntawv teev npe ntawm ICH Cov Lus Qhia Zoo hauv Pharmaceuticals
- Q1F - Cov ntaub ntawv ruaj khov rau kev tso npe thov hauv thaj chaw nyab xeeb III thiab IV.
- Q2 (R1) – Validation of Analytical Procedures: Text and Methodology.
- Q3B (R2) - Cov khoom tsis huv hauv cov khoom siv tshuaj tshiab.
- Q3C (R5) – Impurities: Qhia rau Residual Solvents.
Ntawm no, kev ntsuas kev ntxhov siab hauv kev tshawb fawb txog kev ruaj ntseg yog dab tsi?
Kev ntsuam xyuas kev ntxhov siab ntawm API tuaj yeem pab txheeb xyuas cov khoom lag luam uas yuav degradation, uas tuaj yeem pab tsim txoj hauv kev degradation thiab qhov tseem ceeb. ruaj khov ntawm lub molecule thiab validate lub ruaj khov - qhia lub hwj chim ntawm cov txheej txheem analytical siv.
Lub hom phiaj tseem ceeb ntawm ICH yog dab tsi hauv kev tswj kom zoo?
ICH cov Lub hom phiaj yog ua kom muaj kev sib haum xeeb ntau dua thoob ntiaj teb kom ntseeg tau tias muaj kev nyab xeeb, muaj txiaj ntsig, thiab siab zoo Cov tshuaj tau tsim thiab sau npe hauv cov peev txheej zoo tshaj plaws.
Pom zoo:
Dab tsi yog bureaucracy thiab nws cov haujlwm yog dab tsi?
Cov haujlwm ntawm Tsoom Fwv Teb Chaws Bureaucracy. Tsoom fwv teb chaws bureaucracy ua peb lub luag haujlwm tseem ceeb hauv tsoomfwv: kev siv, kev tswj hwm, thiab kev tswj hwm. Kev ua haujlwm niaj hnub ntawm bureaucracy - sau nqi, muab ntawv tso cai, muab xeem, thiab ntxiv rau - yog kev tswj hwm ntawm nws lub hom phiaj
Dab tsi yog rau lub tshuab yooj yim thiab cov piv txwv ntawm lawv yog dab tsi?
Cov no yog rau lub tshuab yooj yim: cov nplais, lub log thiab lub qag, qib, lub dav hlau inclined, ntsia hlau, thiab lub log
Kev tswj hwm kev paub yog dab tsi nws lub hom phiaj yog dab tsi?
Lub hom phiaj ntawm kev tswj hwm kev paub yog muab cov ntaub ntawv txhim khu kev qha thiab ruaj ntseg, nrog rau ua kom muaj thoob plaws hauv koj lub koom haum lub neej. Muaj peb lub hom phiaj tseem ceeb ntawm KM thiab lawv yog: Ua kom lub koom haum ua haujlwm zoo dua. Xyuas kom txhua tus neeg ua haujlwm muaj kev nkag siab meej thiab sib koom ua ke
Yuav ua li cas yog tias qhov chaw nruab nrab ntawm lub ntiajteb txawj nqus txav tawm sab nraud ntawm daim duab peb sab stability?
Txhua lub sijhawm lub forklift qhov nruab nrab ntawm lub ntiajteb txawj nqus txav tawm sab nraud ntawm daim duab peb sab kev ruaj ntseg, lub elevator yuav tawm mus.Yog tias cov kab hauv qab no mus rau sab nraud ntawm daim duab peb sab kev ruaj ntseg - vim tias lub nra hnyav dhau los yog siab dhau, lossis vim tias lub forklift tsis nyob ntawm qhov chaw - nws yuav tip over
Dab tsi yog diversity stability hypothesis?
Kev ruaj ntseg-diversity hypothesis hais tias ntau haiv neeg muaj ntau haiv neeg, qhov ruaj khov thiab ua tau zoo hauv zej zog. Qhov kev xav no tau tsim los ntawm lub hauv paus uas cov zej zog ruaj khov thiab muaj txiaj ntsig tuaj yeem siv lawv cov peev txheej zoo dua thiab muaj txiaj ntsig zoo dua li piv rau cov zej zog uas muaj ntau haiv neeg tsawg