What is significant change in the stability study?

#stabilitystudy #interviewquestions #pharmaceutical #interview
What is significant change in the stability study?
When a significant change is applicable?
What to do once significant change gets occurs?
Join Pharma growth hub's WhatsApp group here: chat.whatsapp....

[@ramakrishnaguttula7941]

Excellent video sir 👏👏💯

[@vijayagrawal2628]

Dear Sir, It's a very informative video. Request to make video on quality control of solvates, hydrate and polymorph drug substances and drug products.

[@amitgupta-yr5pl]

Very informative 👏

[@shridharvats3335]

Very understanding sir, thank you..

[@anandbhaskar928]

Really nice information

[@jalindardighe4022]

Very good explanation sir

[@bushraqamar2214]

if my product is a sugar base lozenges, which is supposed to be melt at accelerated stability conditions, and when I performed the accelerated stability, assay and other results found satisfactory except appearance (lozenges got deformed due to melting). In this case what should I do, because I have to submit the stability data in drug ministry for product registration.

[@pharmagrowthhub3083]

It is a significant change

[@saravananram3960]

Pls explain evaluation of stability data(ICH Q1E)

[@lingarajubannimarad1696]

What is the significant change for powder for oral suspension where assay limit having 85 to 115%?

[@ganeshbirajdar4599]

sir what is the difference between oos and significant change or both are same

[@jnjayavel5633]

Hi si, plz put video abou particle size distribution by malvern 3000 development

[@ashoksarkar7951]

Sir if absolute significance is at this stage what we can do

[@meetsoni589]

Plese make video hindi language