mayur661 ☆ India, 2010-06-03 16:41 (5513 d 18:31 ago) Posting: # 5428 Views: 4,885 |
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Suppose we do fed BE study in India and US. whether food in diffrent country affect bioequivalece study of same formulation? |
Dr_Dan ★★ Germany, 2010-06-03 17:13 (5513 d 17:59 ago) @ mayur661 Posting: # 5430 Views: 3,757 |
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Hi Food is standardized (fat and calorie content), so bioequivalence results (=food effect on formulation) will be the same in both populations (Indian vs. US) even if the plasma level may vary (due to different body weights and/or metabolism). Regards Dan — Kind regards and have a nice day Dr_Dan |