Bioequivalence and Bioavailability Forum

Dear All,

I would like to Know that regarding the sample size for levothyroxine sodium, I had gone through the all available literature's for sample size the levothyroxine sodium ISCV was found the below 18%. But the sample size was taken 72 or more than 50. if CV is below the 18% THEN what is the reason behind to considered 70 subjects.

Even OGD also It was mentioned as design is fully replicate but all literature's it was mentioned 2 way cross over.

I am thinking due to base line correction, this molecule will show any more variability?

Please guide me levothyroxine is variable drug or not.

if it was not variable in literature why it was mentioned 72 subjects.


thanks & Regards

N. L. D. Prasad