Bioequivalence and Bioavailability Forum

PTM139 ☆ India, 2012-05-03 07:58 (5152 d 01:49 ago) Posting: # 8495 Views: 3,489	Partial replicate design [Design Issues] Post reply
	Do you anticipate any impact of changing the study design from partial replicate design (for pilot BE) to crossover design (for pivotal BE) on the results? Edit: Please follow the Policy. [Helmut]

Dr_Dan ★★ Germany, 2012-05-03 17:17 (5151 d 16:30 ago) @ PTM139 Posting: # 8502 Views: 2,767	Partial replicate design Post reply
	Dear PTM139 A partial replicate design for a pilot study does IMHO not make much sense. For a pivotal study you can change from a cross-over to a replicate design if you observe a high ANOVA CV% in the pilot study. Kind regards Dan — Kind regards and have a nice day Dr_Dan

PTM139 ☆ India, 2012-05-03 18:38 (5151 d 15:09 ago) @ Dr_Dan Posting: # 8506 Views: 2,787	Partial replicate design Post reply
	Dear Dr Dan, Thank you for the reply. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Partial replicate design [Design Issues]