FDA scaling for NTIDs [Design Issues]

posted by krishna – India, 2013-01-07 15:01 (3988 d 14:25 ago) – Posting: # 9795
Views: 7,158

Hi to all,

❝ ❝ "As described for the solution, the intra- and inter-individual variability in trough levels is high (40-50%)"

As per the recent guideline of FDA for warfarin sodium Tablets, they designed the BE acceptance criteria assuming all NTIs are low variable. I have gone thorough the guideline it is very stringent to rest of regulatory.

I want to discuss the guideline here. With no constraint on the point estimate, suggested SABE(sigm0=0.1 and delta=1.11), ABE and upper 90% CL of sigmT/sigmR <=2.5. Suppose if the full replicated study results are like for Cmax: 86.00 (80.00 - 93.00) with %CV: 26, then the study passing with SABE, also with ABE and test variability is less than the Refe variability. Even, in the guideline they didn't mention about cut off for maximum sigmaR. So, what is the advantage of above stringent criteria in this case? Correct me if i am wrongly interpreted?


Edit: Guidance linked and subject line changed. [Helmut]

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