Study costs: Replicate vs. 2×2×2 [Regulatives / Guidelines]

posted by mahmoud-teaima  – 2017-03-23 08:17  – Posting: # 17178
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Hi Helmut,

» Calculation of costs is complicated (fixed & variable costs, blahblah). In my CRO we had a spreadsheet with 100 rows… Had a quick look (19 samples / period, last sampling 16 hours; 2×2×2 in 42 subjects vs. 2×2×4 in 22). The replicate design would be ~4% cheaper. ;-) If you hope for RSABE (for CVwR 31% 18 subjects instead of 22 for ABE) the reduction in costs would be ~12%.

Can you please help me for in the approximate estimation of cost of bioequivalence study?, would you please send me the template sheet that you use for such calculations.

Greetings.

Mahmoud Teaima, PhD.

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