3 period full replicate [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2015-06-24 16:29 (3458 d 22:56 ago) – Posting: # 14976
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Dear Dan,

[image]this statement is outright bizarre (politely speaking). :not really:

❝ What should one reply to this attitude?


Suggest the “leading European regu­la­tory authority” to read some stuff (»Lesen bildet!«).

One of the authors (László Tóth­falusi) is a former member of the PKWP and an­other one (Alfredo García-Arieta) still is:


  1. Tóthfalusi L, Endrényi L, Midha KK, Rawson MJ, Hubbard JW. Evaluation of the Bioequivalence of Highly-Variable Drugs and Drug Products. Pharm Res. 2001;18(6):728–33. doi:10.1023/a:1011015924429.
  2. Tóthfalusi L, Endrényi L. Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products. Pharm Res. 2003;20(3):382–9. doi:10.1023/a:1022695819135.
  3. Tóthfalusi L. Scaled Average Bioequivalence to Evaluate Bioequivalence of Highly Variable Drugs. Presentation at the informa conference “Dissolution Testing, Bioavailability & Bioequivalance”, 24 May 2007, Budapest, Hungary
  4. Tóthfalusi L, Endrényi L, García-Arieta A. Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence. Clin Pharmacokinet. 2009;48(11):725–43.
    doi:10.2165/11318040-000000000-00000.

Edit (after reading the authority’s statement again):

❝ A 3-period full replicate design would result only in two parallel separate groups (one which […] only get Test and the other only Reference) […]



I beg your pardon? :blind:
Sequence 1: TRT only Test?
Sequence 2: RTR only Reference?

❝ an evaluation would probably only possible as a general 2-period crossover study


What? Throw away the data of the third period? They don’t get the terminology right and mix up groups with sequences. If I follow this logic, they could also say:

A 2-period crossover design would result in two separate groups (one which gets Test and Reference in the order TR and the other one in the order RT); an evaluation would probably only possible as two separate paired designs – assuming no period effects.

Gimme a break.
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