Period effect [Off Topic]

posted by Helmut Homepage – Vienna, Austria, 2014-01-28 12:48  – Posting: # 12283
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Hi Kumar & Dan,

although it is interesting that you got only ~20–25% of period 1 in period 2, the behavior is consistent for both formulations and both PK metrics. The ratios are pretty close to 100%.

» This was a oral suspension.

So it might be worthwhile to look for an explanation (were the suspensions in both periods prepared in exactly the same way and by the same personnel?). However, the BE assess­ment and – since this is a pilot study – the estimated PEs and CVs are not affected. The period effect means out in a cross-over study.

Helmut Schütz

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