Reference drug for BE [Design Issues]

posted by nguyenvo – 2006-06-13 23:11 (6133 d 03:39 ago) – Posting: # 145
Views: 8,970

Dear all,

If the original drug was withdrawn from market by the company, what should we choose as reference drug for a BE study?
We are studying BE/BA of 200 mg- cefixime capsule. The reference drug from Wyeth has already withdrawn from market. The another approved by FDA is Lupin (200 mg tablet)is not available.
We have some 200 mg cefixime capsules imported from India and Korea. Can I choose one of them as reference drug in my study and are there any other solutions for this problem?
In the same case, I would like to ask reference drug of gatifolaxin for BE study when Tequin would be withdrawn by Bristol Mayer Squibb?
I appreciate all your advice.

Nguyen Vo

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