FDA: 2×2×4 design; RSABE + ABE + σwT/σwR [Design Issues]

posted by Pharma_88 – India, 2020-03-13 10:14 (991 d 22:51 ago) – Posting: # 21262
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❝ All of the product-specific guidances contain a section ‘Explanation’. See also Yu et al.


OK

❝ ❝ Further, can we perform crossover studies for NTI by taking extra safety measurement in to the study?


❝ You can. Whether that is necessary in healthy volunteers depends on the drug.


Yes.

❝ ❝ 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?


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[Helmut]

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