Bioequivalence and Bioavailability Forum

Dear Amr !

In this kind of studies, the sampling scheme is frequently a problem (i.e. it is not possible to get samples from all animals at all time points planned due to restrictions in blood volume). You may consider using a batch design to overcome these limitations which is for example described in the following papers:

Jaki T and Wolfsegger MJ (2009).
A theoretical framework for estimation of AUCs in complete and incomplete sampling designs.
Statistics in Biopharmaceutical Research, 1(2):176-184.
Abstract

Jaki T, Wolfsegger MJ, Lawo J-P (2010).
Establishing bioequivalence in complete and incomplete data designs using AUCs.
Journal of Biopharmaceutical Statistics, 20(4):803-820.
Abstract

The approaches described in these two papers are implemented in the R package PK:

Jaki T and Wolfsegger MJ.
Estimation of pharmacokinetic parameters with the R package PK.
Pharmaceutical Statistics, published online ahead of print
Abstract

hope this helps

martin

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Edit: Abstracts and package PK linked. [Helmut]