Bioequivalence and Bioavailability Forum

Dear Ohlbe,

Would highly appreciate your comments again on sample reanalysis.

If the repeat is for analytical reason, and the 2nd value is far apart from the initial value, how do we justify the acceptance of the 2nd value ? What are the analytical reasons that can be given ? QCs passed.

❝ ❝ How far the difference in value between repeat and initial value to justify for the third injection ?

If the repeat is for abnormal value, if we repeat in duplicate, which repeat should be taken, the 2rd or the 3nd repeat ?? is the purpose of 3rd repeat for confirmation ? Then, we should take the 2rd repeat as final value ?

Have you ever come across a scenario that the 3rd repeat is different from the 2rd repeat ? Again, what is the specification or criteria we need to set to accept the value ? Can we use ISR as a guide, set 20% as acceptance value ? How do we justify to inspector on this issue ?

Thank you.

Regards,
Ken