Re: Extrapolation to achieve actual half-life
Hi Anuja,
I would be careful about using partial data for model building. You want to be
sure that the structural model is capturing the true behavior of the drug. I
mean that you should not miss a gamma-slope if exists. You may have some prior
information on this drug (as I understand from your description), and may be
worth utilizing that information as prior.
Regards,
Ayyappa
Quoted reply history
> On Mar 14, 2018, at 12:17 AM, Anuja Dhas/Formulation/VKH
> <[email protected]> wrote:
>
> Hello Everyone,
> We have done one parallel study to prove Bioequivalence, which failed on the
> lower side of Cl limits. We want to do crossover study, but in previous study
> we failed to capture actual half life. The API is having a half life around
> 4-5 days and we did a parallel study for 2 days.
>
> By M&S, we want to extrapolate to get actual half-life. And we want to
> calculate the sufficient wash-out period so that the carry-over effect will
> be <5% of Cmax in period 2 of crossover study.
>
> We have achieved final model and done with VPC,LLP, please guide me for
> simulation.
>
>
>
> Thanks & Regards
> Anuja
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