Failed study [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-04-26 22:28 (9 d 02:35 ago) – Posting: # 22327
Views: 221

Dear Ohlbe,

» NK's study is intended for the US FDA, I don't know how these guys react to such exclusions.

IMHO, that would by a case for R-t-R, Section VI.A. because nothing about excluding ‘outliers’ is stated in any of the product-specific recommendations I’m aware of. That’s why I suggested a controlled correspondence for the next study to hope for Section VI.B.

» In Europe, subject B could be excluded according to the EU BE guideline, but subject A could not as the period with all BLQ was after the test product. EU regulators will tell you that this might be due to your product and you can't exclude the data just because they don't suit you. In such a situation: you're screwed.


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Helmut Schütz

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