Evaluation of Reference variability [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2010-03-16 15:01  – Posting: # 4921
Views: 1,868

Dear Marcel!

» My apologies for dragging this replicate skeleton out of the closet when it seemed like it was comfortably resting.

No problem - if you think we need some more forensics, go for exhumation!

» Was there any mention at this meeting as to whether the results of a replicate design study (finding of intra-subject variablility exceeding 30%) with a lower strength can be used to justify widen acceptance limits for a higher strength of the same drug to undergo a standard BE study?

No. Or to be more precise, nobody asked that question, but I would bet the answer would have been a straight "No!" as well.

» If this is not allowed, can someone explain why not?

I would say there are two reasons.

Cheers,
Helmut Schütz
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