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Extrapolation to achieve actual half-life

From: Anuja Dhas-Formulation-VKH <Anuja.Dhas>
Date: Wed, 14 Mar 2018 05:17:07 +0000

Hello Everyone,
We have done one parallel study to prove Bioequivalence, which failed on th=
e 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 a=
round 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 calc=
ulate 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 sim=

Thanks & Regards
''Legally privileged confidential information and subject to "Disclaimer". =

Received on Wed Mar 14 2018 - 01:17:07 EDT

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