Sample Size Benefits of Replicate Design with ABE [Power / Sample Size]

posted by Sereng  – USA, 2023-05-24 17:41 (277 d 00:33 ago) – Posting: # 23566
Views: 1,236

Folks, I have three questions:

(1) If you conduct a full replicate crossover design BE study (T x 2, R x 2, e.g., TRTR|RTRT) is there any sample size efficiency (fewer patients required) with ABE analysis or is it no different (in terms of sample size) than a non-replicate crossover design BE study (T x1, R x 1) with ABE analysis.

(2) For demonstrably HVD (WSV >30%), why do some product specific guidance for ANDA suggest (or allow) full replicate designs and others do not mention this approach?

(3) For demonstrably HVD (WSV >30%), why do some Clinical Divisions object to use of full replicate design studies in 505(b)(2) NDAs?

Any input would be appreciated!

Biostatistically Challenged CEO

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