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RegisterReference drug for BE [Design Issues]
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If the original drug was withdrawn from market by the company, what should we choose as reference drug for a BE study?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 The reference drug from Wyeth has already withdrawn from market.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In the same case, I would like to ask reference drug of gatifolaxin for BE study when Tequin would be withdrawn by Bristol Mayer Squibb?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
If the original drug was withdrawn from market by the company, what should we choose as reference drug for a BE study?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 The reference drug from Wyeth has already withdrawn from market.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In the same case, I would like to ask reference drug of gatifolaxin for BE study when Tequin would be withdrawn by Bristol Mayer Squibb?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
Complete thread:
- Reference drug for BEnguyenvo 2006-06-13 21:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- which country? Jaime_R 2006-06-14 18:07
- which country? nguyenvo 2006-06-15 08:46
- ASEAN States, USA Jaime_R 2006-06-15 14:26
- which country? nguyenvo 2006-06-15 08:46
- which country? Jaime_R 2006-06-14 18:07
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