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lovemysoul ☆ Korea, 2014-05-20 04:57 (4422 d 23:13 ago) Posting: # 12975 Views: 3,961 |
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Dear all, I'm gonna design 2x2 crossover BE study of IR and CR tablet. As you know, IR tablet needs to be administered b.i.d., and its AUC and Cmax have to be compared with PK parameters of CR tablet (q.d.). In this case, how can I control the meals to feed volunteers in IR tablet group? Sampling points are gonna be 0, 0.5, 1, 2, 4, 8, 12, 12.5, 13, 14, 16, 20, 24, 36hr for IR b.i.d. group, 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 36hr for CR q.d. group. IR tablet will be administered at 0h, 12h after blood samples were collected. Lunch will be served 4hr after first dose administration and dinner will be served 8hr after first dose administration. 1. Is there any problem with my design? 2. if the API have some food effect (shows enhanced absorption by food), do i have to change my meal plan? (lunch and dinner will be prepared with FDA standard fat meal)  Thanks for your help Edit: Category and subject line changed. [Helmut] |
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SDavis ★★  UK, 2014-05-21 12:52 (4421 d 15:18 ago) @ lovemysoul Posting: # 12979 Views: 3,034 |
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Have you tried simulating the profile to check that the sampling intervals look reasonable visually ? ![[image]](img/uploaded/image90.jpg) Also with a modelling and simulation approach you can objectively compare sampling schedules to select the one most likely measure your study end points (Cmax and AUC) with most confidence e.g. comparing VIF values Simon PS note of course the model I used above has model parameter values that are probably different from your compound and formulation — Simon Senior Scientific Trainer, Certara™ [link=https://www.youtube.com/watch?v=xX-yCO5Rzag[/link] https://www.certarauniversity.com/dashboard https://support.certara.com/forums/ |
Ing. Helmut Schütz