No way [Dissolution / BCS / IVIVC]
Thanks for your response. I was hoping to justify the waiver on the basis of sameness of finished test product against reference. I understand that criticality still remain since the molecule is BCS II drug. Thank you.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- BCS II waiver approach yuvaneshwari 2019-01-23 06:09 [Dissolution / BCS / IVIVC]
- No way Ohlbe 2019-01-27 18:18
- No wayyuvaneshwari 2019-01-28 05:16
- No way Ohlbe 2019-01-27 18:18