Bioequivalence and Bioavailability Forum

Dear Dr Dan,

Thank you for your prompt reply, do you mean as per WHO all samples are in days which means initially every day there are only two samples till 7.5 days and subsequently only one sample post 8th day? I thought initial samples till 24 are mentioned in hrs and subsequent samples in days, I was wrong.

But FDA submission study has 9 samples on day 1 (i.e. 0.5, 1, 2, 3, 4, 6, 8, 12, 24...) and rest 31 samples distributed over period of 140 days.

Your view please.

Thanking you,

Ratnakar