least common multiple of T and R [Design Issues]
❝ 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.
If possible, can we know the name of molecules to understand the rationale of individual strengths in the proposed FDC and to assess the clinical advantages of proposed FDC against the use on monotherpies.
Is it Aceclofenac/Paracetamol 100/325 mg FDC formulation??
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
- bioequivalence if test and reference formulation having different strengths Vishal S 2021-05-24 09:21 [Design Issues]