Bioequivalence and Bioavailability Forum

The almighty oracle has spoken! [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2015-07-24 01:54 (3612 d 08:23 ago) – Posting: # 15139
Views: 31,765

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 C_max

Essentially it says that CV_wR 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

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

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• 3 period full repli­cate Dr_Dan 2015-06-24 13:55 [RSABE / ABEL] 
  • 3 period full replicate ElMaestro 2015-06-24 14:11
  • 3 period full replicate Helmut 2015-06-24 14:29
  • 3 period full replicate d_labes 2015-06-24 14:38
    • 3 period full replicate Dr_Dan 2015-06-24 16:43
      • 3 period full replicate Helmut 2015-06-24 18:00
        • 3 period full replicate ElMaestro 2015-06-24 18:11
          • 3 period full replicate Helmut 2015-06-24 18:25
            • 3 period full replicate d_labes 2015-06-25 08:52
              • 3 period full replicate ElMaestro 2015-06-25 10:37
                • OT d_labes 2015-06-25 11:20
                  • OT ElMaestro 2015-06-25 11:54
                    • OT d_labes 2015-06-25 13:51
      • CVs (borderline OT) Helmut 2015-06-26 13:51
        • CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
          • Answering an un­asked ques­tion Helmut 2015-07-02 13:03
            • Answer to an un­asked answer d_labes 2015-07-02 14:21
              • Bloody typo! Helmut 2015-07-02 14:33
        • CVs (borderline OT) zizou 2015-07-05 19:20
          • Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
            • Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
              • Degrees of freedom 3-period full replicate d_labes 2015-07-06 13:53
            • Degrees of freedom 3-period full replicate zizou 2015-07-06 17:25
  • The almighty oracle has spoken!Helmut 2015-07-23 23:54
    • Almighty oracle's mysterious saying d_labes 2015-07-24 08:23