Bioequivalence and Bioavailability Forum

Dear Debbie and VP,

❝ i am wondering what partal validation you have performed?

❝ since when you have extended the calibration range, you should perform the

❝ complete validation.

Well... As I heard in a recent presentation, if you want to call it a partial validation because you won't study stock solution stability again Why not ? And selectivity is already done too.

But indeed you have to go back to linearity, within and between run precision and accuracy, stability experiments, etc.

Regards
Ohlbe