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 designs, see this article: https://www.ncbi.nlm.nih.gov/pubmed/26463060 Much of the reasoning could be applied for bio-equivalence too, so I hope you find it helpful.
Good luck! Elin From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On Behalf Of Anuja Dhas/Formulation/VKH Sent: den 14 mars 2018 06:17 To: nmusers@globomaxnm.com Subject: [NMusers] Extrapolation to achieve actual half-life 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 ''Legally privileged confidential information and subject to "Disclaimer". <http://www.cipla.com/Home/Other/Disclaimer.aspx>
