Evaluation of Reference variability [Design Issues]

posted by Marcel – 2010-03-16 14:10 (5943 d 12:29 ago) – Posting: # 4920
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(edited on 2010-03-16 14:54)

❝ Same opinions were expressed at the EUFEPS meeting last January (see this thread), where almost the entire PK group of EMEAas present. The group univocally expressed their point of view that a two period replicate design (reference only) is not acceptable.


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

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?

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

Thank you in advance.

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]

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