Bioequivalence and Bioavailability Forum

Hello Everyone,

I have faced following issue,

I have found concentration in pre-dose sample and that concentration is higher than last sample / time point of Period 01 (i.e. P02, pre-dose concentration is higher than its preceding sample).

In such case we need to repeat the sample (i have repeated sample).

My doubt is,

If i found repeated value different from initial value then what to do? we need to accept which value??? (Initial / Repeated / we need to reported as NR)


eg.

Initial Value - 251 ng / mL
Repeated Value - 0.oo ng / mL (totally different value)

Please give me your suggestions.

Regards,
Mitesh Panchal