Chromatography Forum

Hi,

Anybody can clearify one point about the FDA guidence for bioanalytical method validation?

e.g. " accuracy should be determined by replicate analysis of samples....." does this mean replicate injection from the same sample vial or replicate sample preparation? It would be really appreciate if any of you could summarize when we should do replicate injection and where should we do the replicate sample preparation. Thanks a million.

Also I am working with bioanalytical method validation, according our SOPs and FDA guidence, you should replicate sample preparation.
For QC samples, at least four level conc. , each conc. should have six replicate.
For C samples, at least six level conc. , each conc. should have 2 replicate.

my E-mail address: lcms@shmobile.com