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Registerleast common multiple of T and R [Design Issues]
Hii Helmut
Thank you for replay
we are designing the fixed dose combination Immediate release test formulation(A+B) having strength 100 mg (A) and 325 mg (B), RLD for FDC formulation not approved in EU market & not available so we are using two different RLDs ie RLD (A) of 100 mg strength and RLD (B) having 500 mg strength. Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD.
please guide me for BE study for same
Thanks and Regards
Vishal S
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]
Thank you for replay
we are designing the fixed dose combination Immediate release test formulation(A+B) having strength 100 mg (A) and 325 mg (B), RLD for FDC formulation not approved in EU market & not available so we are using two different RLDs ie RLD (A) of 100 mg strength and RLD (B) having 500 mg strength. Note than RLD (B) available in EU market in 500 mg strength, 325 mg strength not available as RLD.
please guide me for BE study for same
Thanks and Regards
Vishal S
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]
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 RVishal 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 R Helmut 2021-05-26 00:23
- least common multiple of T and RVishal S 2021-05-25 13:26
- least common multiple of T and R Helmut 2021-05-24 12:32
Ing. Helmut Schütz