ICH stability test yog dab tsi?
ICH stability test yog dab tsi?

Video: ICH stability test yog dab tsi?

Video: ICH stability test yog dab tsi?
Video: ICH Guideline Stability Testing of New Drug Substances and Products Q1A(R2) 2024, Kaum ib hlis
Anonim

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: