The almighty oracle has spoken! [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2015-07-23 23:54 (2094 d 07:22 ago) – Posting: # 15139
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Dear Dan et alii,

today the EMA published Rev. 12 of the Q&A-document (dated 25 June). See #23

Suitability of a 3-period replicate design scheme for the
demonstration of within-subject variability for Cmax

Essentially it says that CVwR is a “key parameter” and according to the GL a minimum of 12 subjects is needed for a “valid” BE study. In other words – and contrary to what the “leading European regulatory authority” told you – TRT|RTR is indeed acceptable if (‼) at least 12 subjects complete the RTR sequence.

Given the commonly applied T/R-ratio of 0.90 for HVD(P)s and ≥80% power this issue is practically not rele­vant. Full throttle for any study – unless you expect a lot (≥42%) of dropouts!

CVwR   N  nRTR  do.ratemax (%)
 25   42   21      42.9
 30   50   25      52.0
 40   40   20      47.8
 50   42   21      42.9
 60   48   24      50.0
 70   60   30      60.0
 80   74   37      67.6


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Parturient montes, nascetur ridiculus mus. Horace (Ars poetica, Ep.II.3, 139)

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Helmut Schütz
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