Sample Size Estimate in BE Studies [Power / Sample Size]

posted by Sereng  – USA, 2022-05-12 17:22 (14 d 23:54 ago) – Posting: # 22976
Views: 189

Dear colleagues, in BE studies that must be conducted as parallel group design (e.g., depot formulations with sampling for 2 to 3 months), (i) is the sample size generally the same when compared to crossover design studies? and (ii) how do you estimate sample size when the known CV of the reference drug is excessive and much higher (e.g., double or triple) than the estimated CV of the Test drug? Regards

Biostatistically Challenged CEO

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