Bioequivalence and Bioavailability Forum

Dear Mr John,

❝ I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required.

As per Old FDA's BE Guidance on Single dose, three way cross over, food/fasting study, six sequences should be used.

Quote from the Old FDA’s BE guidance
“A single dose, randomized, three-treatment, three period, six sequence, crossover, limited food effects study, comparing equal doses of the test product administered under fasting conditions with those of test and reference products administered immediately after a standard breakfast”. (Refer page 3 of the Old FDA's BE Guidance)

“Equal number of subjects should be randomly assigned to each of the six dosing sequences” (Refer page 10 of Old FDA's BE Guidance)