Guidance for industry bioanalytical method validation (FDA)

thanks a lot!
it is more strict than we cited. especially in lower limit of quatification, LLQD should be at least 5 times the response compared to blank response, but we often think 3 times is OK, and it hard to do.

I think "3 times is OK" is for LOD, not for LLOQ!

We usually think that the LLOQ should be 10 times