Bioequivalence and Bioavailability Forum

Hi All,

Greetings!

Kindly correct me if anyone of the following steps of mine are not correct.

I am doing my first project on IVIVC by using WinNonlin IVIVC Tool-kit:

Data:

1. In-Vitro Data: 3 formulations at different PH values 7,4.5 & 6.8 (R=ref, T=Optimum Release, T1= Fast Release)
   
2. In-Vivo Data: (1. Fully Rep (TRTR & RTRT) (In Lieu of optimum Release); 2. Two way cross-over (T1R & RT1) (In Lieu of Fast Release)

Procedure:

1. I have merged the data of Fully replicate and Two way crossover in a single sheet to form In-Vivo Data
   
2. In the toolkit I have taken (T & T1) as internal Validation in the In-Vitro tab and R as reference formulation in the In-Vivo tab.

Result:
1. After running the software got the following results for:
PH-4.5

Form      Parameter  Predicted  Observed  % PE  Ratio

T(mean)     AUC_last   150.006      136.457   9.9     1.10
            Cmax       2.738        4.968     -44.9   0.55

T1(mean)    AUC_last   158.253      168.9719   -6.3   0.94
            Cmax       2.994        7.437      -59.7  0.40

Avg         AUC_last   154.129      152.714     8.1   1.01
            Cmax       2.866        6.202       52.3  0.46

Since %PE for AUC_last is <10% and not for Cmax.
Does that mean IVIVC is not established?

Thanks & Regards
Anu Jaswal

---

Edit: Subject line changed, lists and table BBCoded. [Helmut]