Bioequivalence and Bioavailability Forum

Prasad Tata ☆ 2013-01-04 16:14 (4923 d 03:27 ago) Posting: # 9784 Views: 3,924	Preferred study design for RSABE [Design Issues] Post reply
	I am looking at diffeent study designs for the Bioequivalence trials. When applying for scaled bioequivalence which study design is superior and gives control over the 90% CI for a highly variable drug.1) 3-way cross over (TRR, RTR, RRT) or 4-way cross over (RRTT, RTRT etc.) Any guidance with references or right examples will greatly help me. Prasad Tata Edit: Category changed. [Helmut]

jag009 ★★★ NJ, 2013-01-04 16:38 (4923 d 03:03 ago) @ Prasad Tata Posting: # 9785 Views: 3,242	Preferred study design for RSABE Post reply
	Hi Prasad, Check papers from Dr. Laszlo Endrenyi. 4-way fully rep design advantage? 1) further reduction in study sample size, 2) obtain information about the intrasubject variability of the test formulation. Disadvantages? Longer to run and potential dropouts. Most are happy with 3-way rep. John

Preferred study design for RSABE [Design Issues]