Bioequivalence and Bioavailability Forum

Dear Vishal,

❝ After re-injection, re injected QCs are passing and batch

❝ is within acceptance criteria. Can we accept this batch?

❝ ISTD response found constant throughout batch.

I would avoid this type of practice. The batch was not failed yet when you stopped it (2/8 is less than 33 %). The question could now be: did the QCs first fail by accident, or did they eventually pass by chance ? As you have not identified the reason for failure (the response was lower, but why ?) you will not be able to demonstrate that the second injection is "better" and more reliable than the first.

❝ 2. In BE study, if number of batch failure in bio analytical analysis is

❝ more (more than 10%) then required to file any investigation for same.

There is no limit given in the FDA guidance or in the draft EMA guideline. But if you have repeated batch failure you will indeed be expected to investigate why, and to document your investigations.

regards
Ohlbe