Vyas ☆ India, 2016-10-25 16:30 (2711 d 02:03 ago) Posting: # 16753 Views: 2,183 |
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Hi All, Almost all regulatory bodies emphasize on pre & post dosing fluid restriction in BE studies. I agree on one of the main assumptions in a cross-over setting which is constant clearances within study periods. What is FDA's thinking on allowing milk (fluid) to be served to the subjects 30 minutes prior to dosing as a part of high fat breakfast & restricting other fluids one hour before and after drug administration Best regards, Vyas |
Dr_Dan ★★ Germany, 2016-11-02 16:21 (2703 d 01:11 ago) @ Vyas Posting: # 16766 Views: 1,604 |
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Dear Vyas If you consider the composition of the high fat breakfast recommended by FDA than you can imagine that you will need some fluid to swallow this meal and milk supports the idea of a high fat breakfast. — Kind regards and have a nice day Dr_Dan |