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Re: Extrapolation to achieve actual half-life

From: Ayyappa Chaturvedula <ayyappach>
Date: Thu, 15 Mar 2018 12:25:48 -0500

Hi Anuja,
I would be careful about using partial data for model building. You want to b=
e 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 p=
rior information on this drug (as I understand from your description), and m=
ay be worth utilizing that information as prior.


> On Mar 14, 2018, at 12:17 AM, Anuja Dhas/Formulation/VKH <Anuja.Dhas
.com> wrote:
> Hello Everyone,
> We have done one parallel study to prove Bioequivalence, which failed on t=
he lower side of Cl limits. We want to do crossover study, but in previous s=
tudy we failed to capture actual half life. The API is having a half life ar=
ound 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 cal=
culate 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 si=
> Thanks & Regards
> Anuja
> ''Legally privileged confidential information and subject to “Disc=

Received on Thu Mar 15 2018 - 13:25:48 EDT

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