Bioequivalence and Bioavailability Forum

joyjac ★ Philippines, 2011-07-05 09:53 (5465 d 08:49 ago) Posting: # 7207 Views: 6,260	EMA: Two-Stage design [Two-Stage / GS Designs] Post reply
	Hi colleagues, The EMEA guideline states that it is acceptable to use a two-stage approach when attempting to demonstrate bioequivalence. Can anyone enlighten me on this kind of study design, steps to be taken, stopping criteria or can we automatically switch to stage 2 if the BE fails at stage 1? Thanks and regards. Edit: Category changed. [Helmut]

Helmut ★★★ Vienna, Austria, 2011-07-05 21:38 (5464 d 21:04 ago) @ joyjac Posting: # 7211 Views: 5,152	EMA: Two-Stage design Post reply
	Dear Joy, EMA does not specify a particular method. One of them (Potvin et al. 2008) we have discussed numerous times in the forum. See e.g. this post. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes

EMA: Two-Stage design [Two-Stage / GS Designs]