Replies to post #125707 on Elite Pharmaceuticals Inc (ELTP)

[BuddyGuise]

The pivotal study showed low and high doses to be bioequivalent, but when conducting a larger b/e study, the UAC showed bio-equivalence but not for peak concentration (Cmax)....so they did a pilot study where they determined a repeat bio-equivalence study of 32 or more should be conducted in October.....meaning, they need a bigger sample size.

[inveterate]

Sharpei is a valued contributor to this board who was merely trying to assist you.