Bioequivalence and Bioavailability Forum

Dear unique_one,

I will slightly disagree with Mr. Anand.

As the published literature suggest cv less than 30% and anomalous data are found in your study for 2 subjects. Try evaluating the data excluding this two subjects.

For which regulatory the submission is intended. If it is for USFDA you should consider AUCinf for the sample size estimation based on your presented data (required n=102). Do a literature search if your drug undergo enterohepatic circulation or not? Is the drug product IR formulation and truncation is possible? Is OGD available? Are you talking about deviating from OGD and intend to conduct RASBE study from the data of pilot study?

Based on the presented data GMR of Cmax is close to unity and AUCt is about 93. I don’t think your formulation team may consider reformulating the drug product.

Kindly provide data excluding two subject and reported intraCV in literature for further consideration.

Hope this helps.

Regards,
pjs