Obinoscopy ★ USA, 20180625 19:48 Posting: # 18961 Views: 2,431 

Hi guys, Was reading the textbook: Design and Analysis of Bioavailability and Bioequivalence Studies by SheinChung Chow and Jenpei Liu. A nice book for a beginner like me (although I'm still looking for a much more simplified book). However I noticed they only considered carryover factor, formulation factor and the period factor in the ANOVA model. I don't get to see the sequence factor as stipulated in the WHO guidelines. Could it be that the Carryover factor is one and same as the Sequence factor? I'd appreciate is someone could explain this to me as if I were a kindergarten pupil . Regards, — Scopy 
Helmut ★★★ Vienna, Austria, 20180626 12:38 @ Obinoscopy Posting: # 18966 Views: 2,208 

Hi Scopy, » […] (although I'm still looking for a much more simplified book). Maybe Hauschke et al.^{1} » However I noticed they only considered carryover factor, formulation factor and the period factor in the ANOVA model. I don't get to see the sequence factor as stipulated in the WHO guidelines. » Could it be that the Carryover factor is one and same as the Sequence factor? Exactly. They are synonyms. An equal carryover does not hurt (will not bias the treatment effect). However, an unequal one will. » I'd appreciate is someone could explain this to me as if I were a kindergarten pupil . I’ll try. Which factors do we have in a 2×2 crossover? Subjects^{2} (1–n), treatments (T and R), periods (1 and 2), and sequences (RT and TR). Actually we have two groups of subjects, one is treated in the order RT and the other in the order TR. Hence, in the statistical literature (not about BE) sometimes you find ‘group’ instead of ‘sequence’… Let’s explore which effects will influence the treatment effect. Simple example: Untransformed data, true values of the reference 100 and of the test 95, balanced sequences. Therefore, we can work with unadjusted means.
— Cheers, Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
Obinoscopy ★ USA, 20180701 02:20 @ Helmut Posting: # 19004 Views: 2,000 

Wow, thanks. You actually made it look as easy as ABC and 123....just like Kindergarten class I love those examples/illustrations. If only we can have Textbooks on different BE topics with examples/illustrations (both practical examples and hypothetical examples), there will be less than 5% of Type 1 Errors in all BE Studies. Hope you are coming out with books on BE? I am already on the waiting list. — Scopy 
Helmut ★★★ Vienna, Austria, 20180701 12:14 @ Obinoscopy Posting: # 19005 Views: 2,003 

Hi Scopy, » I love those examples/illustrations. THX for the flowers! Two others in this post. » If only we can have Textbooks on different BE topics with examples/illustrations (both practical examples and hypothetical examples), there will be less than 5% of Type 1 Errors in all BE Studies. Well, most of the studies I receive for review failed by design. One can’t get the right answer for a wrong question… » Hope you are coming out with books on BE? I am already on the waiting list. Sorry (see there). — Cheers, Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 