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chloe ☆ China, 2016-04-27 06:44 (3244 d 06:57 ago) Posting: # 16242 Views: 5,448 |
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Dear All: In the FDA "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" guideline, it indicates that "If the label of a modified release RLD product states that the product can be administered sprinkled in soft foods, we recommend applicants conduct an additional BE study." and "Aside from administration in the soft food, this additional study should follow the recommendations for the fasting BE study described in the Appendix.". Does that mean if RLD can be administered sprinkled with applesauce, the ANDA product should conduct an additional fasting sprinkle-in-applesauce BE study? why do this additional BE study can be in fasting condition only? Does there have any evidence indicating that sprinkle BE study could not include fed condition? Regards chloe |
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d_labes ★★★ Berlin, Germany, 2016-04-27 09:50 (3244 d 03:51 ago) @ chloe Posting: # 16243 Views: 4,486 |
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Dear chloe! How would you administer food (soft or whatever, sprinkled with drug) to a fasting man or women without interrupting his/her fasting? — Regards, Detlew |
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chloe ☆ China, 2016-04-27 10:59 (3244 d 02:42 ago) @ d_labes Posting: # 16244 Views: 4,565 |
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Dear Detlew: In the sprinkle BE study, the food (like applesauce or other soft food) administered with sprinkles is just a substance to assist patients to swallow drug products. Unlike fed studies test meal (high-fat, high-calorie), The amount of these soft food is very small, often just a spoonful. In the FDA guideline, the sprinkle BE study should follow the recommendations for fasting BE study. - regards chloe |
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jag009 ★★★ NJ, 2016-05-10 01:14 (3231 d 12:27 ago) @ chloe Posting: # 16286 Views: 4,220 |
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Hi, ❝ Does that mean if RLD can be administered sprinkled with applesauce, the ANDA product should conduct an additional fasting sprinkle-in-applesauce BE study? At least in most (if not all guidances) I have read. John |
Ing. Helmut Schütz