Dear all,
According to EMA/FDA/ICH guidelines, there's a full description of the comparator product where they emphasize that the difference with the test product shouldn't exceed +/-5% but there's no recommendation if we can use multiple batches of comparator product or a single one as always recommended by CRO. Any one has an answer or a reference please
Dear Ahlem,
Preferably multiple batches should be used so as to validate the results more accurately.
Thank you Dr.Kour for your answer.
Do you mean that in each period of the BE study we can use a different batch of the originator ? Or you are talking about the choose of the comparator product that it needs to be chosen by testing different batches ?
You can use multiple batches. It is advised in many guidances from the regulatory agencies- to use products from different batches during the clinical study. Just make sure to list all the batch info in the study report.
CPMP/EWP/QWP/1401/98: "it is advisable to investigate more than one single batch of the test and reference products."
However, to limit the variability of a BABE study, often Pharmaceutical-equivalence is studied for different batches, and the most suitable batch is used for the clinical trial. There are no restrictions to using only single-batch if justified properly.
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