S × F interaction [Design Issues]

posted by Achievwin – US, 2023-06-08 12:21 (407 d 10:43 ago) – Posting: # 23581
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I agree switchability can only be studied by full replicate design, follow up question is now that partial replicate or reference replicate are GONE (??? really) in the new statistics guidance can we study switchability by 3-period replicate design (as it is balanced)....


Can we measure the additional parameter needed for NTIDs by 3-period replicate (balanced design)

"Applicants should use the average bioequivalence approach with BE limits of
80-125%. The within-subject variability of test and reference products should be
compared and the upper limit of the 90% confidence interval for the test-to-reference
ratio of the within-subject variability should be ≤ 2.5. For details about the Method for
Statistical Analysis comparing within-subject variability of test and reference products,
refer to Guidance on Warfarin Sodium."

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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