least common multiple of T and R [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-05-26 02:23 (1122 d 16:55 ago) – Posting: # 22367
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Hi Vishal,

❝ we are designing the fixed dose combination Immediate release test formulation(A+B) […] 325 mg(B) […] Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD.

  1. There are no reference-listed drugs in Europe.
  2. Did you bother reading the section I linked in my previous post? BE means always comparing BA of the same doses. An adjustment$$\small{\frac{f_\textrm{T}}{f_\textrm{R}}=\frac{AUC_\textrm{T}\,\cdot D_\textrm{R}}{AUC_\textrm{R}\,\cdot D_\textrm{T}}}$$would not be acceptable.

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