at best half baked [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2016-04-21 02:43 (3223 d 13:30 ago) – Posting: # 16229
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Hi John,

❝ So they allow a partial replicate as well? The Same as FDA :-|


You used the wrong emoticon. Correct: :-(
Replicate designs are generally acceptable for HC:

Replicated cross-over designs may also be used, where the formulations are tested more than once in the same subjects.


After last June’s meeting László wrote to me “One step ahead, three steps back!”

[image]Some thoughts:
  1. Wonnemann M, Frömke C, Koch A. Inflation of the Type I Error: Investigations on Regulatory Recommendations for Bioequivalence of Highly Variable Drugs. Pharm Res. 2015;32(1):135–43. doi:10.1007/s11095-014-1450-z.
  2. Muñoz J, Alcaide D, Ocaña J. Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs. Stat Med. (early view 28 Dec 2015). doi:10.1002/sim.6834.
  3. Endrényi L, Tóthfalusi L. Regulatory Conditions for the Determination of Bioequivalence of Highly Variable Drugs. J Pharm Pharmaceut Sci. 2009;12(1):138–49. [image] free resource.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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