Different doses or strenghts? [General Sta­tis­tics]

posted by Dr_Dan  – Germany, 2013-11-21 16:23 (3672 d 00:24 ago) – Posting: # 11937
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Dear kumarnaidu
You are talking about a two period cross-over study with 4 treatments, right?
I am not a statistician but I guess it would be reasonable to divide R also into 3 groups with 5 subjects each so that you have an intra-individual comparison T1 vs R1, T2 vs R2 and T3 vs R3. If possible I would prefer a 4 way cross over design, three times test one reference with 5 subjects each.
Bioequivalence: Two medicinal products are bioequivalent if they are pharmaceutically equivalent and if their bioavailabilities after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, will be essentially the same. I guess in your case we are talking about comparative bioavailabilities and the test products are no pure generic formulations, right?
Kind regards

Kind regards and have a nice day

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