Bioequivalence and Bioavailability Forum

Dear Sadia,

please read this post first!

❝ actully i am intrested in bioequivalance study of cefaclor or cefixime.

❝ My frind was told me tht drugs with shorter half life and good

❝ bioavailability are best for this study. is that true?

Your friend is probably wrong.
Finding a sampling schedule for drugs with short half lives can be quite challenging. Define 'good bioavailability'. There are drugs with quite high first pass matabolism (i.e., low absolute bioavailability) which still show only moderate variability. But your friend is right that drugs with high absorption are generally easier to handle.

❝ i do work in a pharmaceutical firm so want to comparison our cefaclor or

❝ cefixime with other leader brands,

Is you drug already marketed? Bioequivalence means the comparison of a test product with the inovator. Or do you want to run such a study just for fun (=marketing purposes).

❝ i was read tht 14 volunteers are required for this this study plz kindly

❝ guide me how many minimum volunteers are required for the study

the literature for previous studies. Both drugs show low variability for AUC and moderate for C_max. If your regulation does not allow widening of the acceptance range for C_max (from 0.80-1.25 to 0.75 to 1.33) a sample size of 14 subjects will be too low. BTW, the regulatory acceptance of widening is doubtful for a drug with low variability.