My record: ≈400 [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2024-05-03 16:19 (46 d 00:40 ago) – Posting: # 23980
Views: 1,855

Hi Achievwin,

❝ ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers…

❝ wow for a full replicate N=400 the sponsor has deep pockets…

Nope. ≈400 (parallel), 180 4-period full replicate1 but there are even larger ones (252 subjects started, 238 completers).2 If your drug is a blockbuster1 and you have to change the formulation, you would do it.

  1. U.S. National Library of Medicine [2014-05-19] – Identifier NCT01290757
  2. Davit BM, Patel DT. Bioequivalence of Highly Variable Drugs. In: Yu LX, Li BV, editors. FDA Bioequivalence Standards. New York: aapspress/Springer; 2014. p. 151–2.

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