3 period full replicate [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2015-06-24 16:11 (3221 d 00:44 ago) – Posting: # 14975
Views: 28,964

Hi Dr_Dan,

❝ My interest is just of academic nature: What should one reply to this attitude?


How about something like:

"From a statistical perspective the added value of a fully replicated trial, in contrast to a semi-replicated trial, is that it contributes direct information about the within-subject variability for the Test product. This information has, however, in its own right no regulatory use because:
  1. Population bioequivalence and individual bioequivalence are abandoned concepts.
  2. Reference-scaled bioequivalence relies solely on estimates of Test and Reference fixed effects along with within-subject variability associated with the Reference product (all of which are provided via a semi-replicated trial).
A fully replicated trial involves four periods with IMP administration to each subject, while a semi-replicated trial involves just three periods with IMP administration. From the perspective of the trial subject the burden associated with the fully replicated design is higher. Since the additional information obtained in a fully replicated trial does not contribute towards the average bioequivalence conclusion -regardless of whether scaling is actually applied or not- it is contended that the fully replicate design is associated with added risk but not additional benefit. In accordance with GCP clause 2.2 the fully replicated design therefore has no obvious merit."

:-)
—
Pass or fail!
ElMaestro

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