LINEARITY (ICH vs ANVISA)

This video will help you to how to perform linearity study during method validation as per ICH & ANVISA, what are similarities and differences between two guidelines.

[@rahulkulkarni3037]

Most of the people are not aware about ANVISA guideline about Linearity.Thank you for teaching us beautifully.

[@pharmagrowthhub3083]

Glad you think so, Rahul! thank you!

[@PRAVEENKUMAR-xb6sb]

Wonderful presentation 👏 Sir I want to know ANOVA (analysis of variance) how to calculate this and how to interpretation of this statistical data, Sometimes ANVISA asking for this also And put some light on t-95 upper and t 95 lower. I have some confusion regarding this. Thank you.

[@krish_krish354]

Any limit for residuals and bias at 100% and homoscedticity

[@AkshayRajHendre54]

According to ANVISA, "The solutions used for the evaluation of linearity must be prepared independently and diluted solutions from the SAME MOTHER SOLUTION of the CRS can be used." Where they says three different stock solutions must be prepare?

[@JayPatel-kr3ip]

Please prepare a video on all calculation parameters like the residual sum of squares.

[@pharmagrowthhub3083]

Hello Jay. Please find a video on the calculation of the residual sum of squares for your kind information. Link: kzbin.info/www/bejne/rJm5c6Kiga52a7s

[@JayPatel-kr3ip]

@@pharmagrowthhub3083 Thank you for reply. I am talking about ANVISA calculation parameter such as homoscedasticity, angular coefficient, and 5% significance level in full calculation.

[@sushmagupta2787]

As per FDA regulations if intercept more than 2 then linearity shall not be accepted. Please make clarity, if is there situation like this How to resolve

[@pharmagrowthhub3083]

You may narrow down the range, in case of not meeting acceptance criteria. High background noise (for instrument methods) and residuals may lead to high bias.

[@krish_krish354]

Can you say the guidelines reference no for intercept nmt 2

[@krish_krish354]

Sensitivity should be high any criteria

[@krish_krish354]

Make video for 5 % significance level

[@vishalgagare3783]

Hi Sir please tell me limit of %Y intercept why is +-10%