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Registerleast common multiple of T and R [Design Issues]
posted by Helmut 
– Vienna, Austria, 2021-05-26 00:23 (362 d 22:28 ago) – Posting: # 22367
Views: 1,036
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.
» 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.
- There are no reference-listed drugs in Europe.
- 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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Dif-tor heh smusma 🖖
Helmut Schütz
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Complete thread:
- bioequivalence if test and reference formulation having different strengths Vishal S 2021-05-24 09:21 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- least common multiple of T and R Helmut 2021-05-24 12:32
- least common multiple of T and R Vishal S 2021-05-25 13:26
- least common multiple of T and R drgunasakaran1 2021-05-25 14:22
- least common multiple of T and RHelmut 2021-05-26 00:23
- least common multiple of T and R Vishal S 2021-05-25 13:26
- least common multiple of T and R Helmut 2021-05-24 12:32
Ing. Helmut Schütz