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RegisterExcipients [Dissolution / BCS / IVIVC]
My bad. 
I meant effect of food on the excipient of the test product.
With this kind of data, I would look at the ratios for fast and fed. I think in this case, as suggested by Helmut (small sample size), might be a better indicator for you.
Looks bad IMHO, the test formulation was too high in bio (Cmax and AUC) under fasting and too low under fed. Big food effect. What is the Tmax values? median please. Check potency difference?
John
I meant effect of food on the excipient of the test product. With this kind of data, I would look at the ratios for fast and fed. I think in this case, as suggested by Helmut (small sample size), might be a better indicator for you.
Looks bad IMHO, the test formulation was too high in bio (Cmax and AUC) under fasting and too low under fed. Big food effect. What is the Tmax values? median please. Check potency difference?
John
Complete thread:
- Similar dissolution rate but Failed BE study wanabby 2012-09-26 03:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS II… Helmut 2012-09-26 14:20
- Similar dissolution rate but Failed BE study jag009 2012-09-27 21:29
- Excipients Helmut 2012-09-29 14:00
- Excipientsjag009 2012-10-01 22:35
- test or reference? Helmut 2012-10-02 19:58
- Excipientsjag009 2012-10-01 22:35
- Excipients Helmut 2012-09-29 14:00
- Similar dissolution rate but Failed BE study ElMaestro 2012-10-01 23:06
Ing. Helmut Schütz