Reporting RSABE to the FDA [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2013-05-03 03:03 (4803 d 17:51 ago) – Posting: # 10530
Views: 6,355

Dear all,

interesting form:

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I thought that the T/R Ratio (⊂ [0.8000, 1.2500], sWR (≥ 0.294), and the upper one-sided 95% CI (≤ 0) are enough to demonstrate RSABE.
Obviously they want the 90% CI as well (nice to know!) and the s²WR (to check whether we are able to take its square root?). Any ideas what they might mean by Method Used?

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