[NMusers] RE: Extrapolation to achieve actual half-life

From: Elin Svensson <elin.svensson_at_farmbio.uu.se>
Date: Thu, 15 Mar 2018 06:55:49 +0000

Dear Anuja,

We did some work looking at study design for drug-drug interaction studies =
with drugs having a long half-life, comparing parallel and cross-over desig=
ns, see this article:
Much of the reasoning could be applied for bio-equivalence too, so I hope y=
ou find it helpful.

Good luck!

From: owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com] On=
 Behalf Of Anuja Dhas/Formulation/VKH
Sent: den 14 mars 2018 06:17
To: nmusers_at_globomaxnm.com
Subject: [NMusers] Extrapolation to achieve actual half-life

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 Thu Mar 15 2018 - 02:55:49 EDT

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