PE restriction for HVDs/HVDPs; testing effects [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2015-04-21 19:12 (3264 d 14:18 ago) – Posting: # 14729
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Hi John,

❝ You guys are messing with me... If the T/R Ratio is <0.8 or >1.25, how can you generate a 90 CI that is within 80.00 – 125.00 since the 90% CI consists of (PE ± values)?


If we are dealing with unscaled ABE, ElMaestro’s answer (and your doubt) is correct: No way.

VSL’s post is ambiguous:

❝ Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.


If the study was reference-scaled, the (implied) BE limits may be much wider (my answer).
Example in FDA’s flavor: CVWR 60%, implied limits 60.96–164.04%, CI 97.00–162.00%; would pass (CI within limits), but fail due to the PE of 125.36 >125.00%.

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