Evaluation of Reference variability [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2009-04-17 11:44  – Posting: # 3555
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Dear Nirali,

I agree with Ohlbe. Same opinions were expressed at the EUFEPS meeting last January (see this thread), where almost the entire PK group of EMEA was present. The group univocally expressed their point of view that a two period replicate design (reference only) is not acceptable. See also Jan Welink's presentation (slide 22).
On the other hand I know of European companies running such studies right now (despite clear reservations by regulators). Obviously these companies are sure that they will be able to convince authorities that the performance was not sloppy. I would not bet on their success!

Helmut Schütz

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