FDA: NTID and “HVNTID” [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-03-13 10:35 (311 d 06:26 ago) – Posting: # 21265
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Hi Pharma_88,

» » » Further, what is the BE limit for such drugs?
» »
» » It depends on \(\small{s_{wR}}\) observed in the study, i.e., reference-scaling is applied. Furthermore – irrespective of passing the scaled limits – the study has to pass 80.00–125.00% as well and the upper confidence limit of \(\small{\sigma_{wT}/\sigma_{wR}}\) has to be ≤2.5.
»
» its common for all NTI or its varies from drug to drug?

The former. Check the guidances I linked above. Maybe there are more, do your homework.

There are exceptions: “Highly variable narrrow therapeutic index drugs”. AFAIK:2×2×4 design, conventional ABE with 80.00–125.00%, upper CL of \(\small{\sigma_{wT}/\sigma_{wR}}\) ≤2.5.
Certain inclusion criteria to decrease risk of bleeding (prothrombin time and activated partial thromboplastin time within their normal ranges, creatinine clearance ≤50 mL/min).

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