Confusing… [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2013-04-03 15:42 (4425 d 07:58 ago) – Posting: # 10333
Views: 9,765

Hi John!

❝ According to the FDA progesterone guidance, the 3-sequences for a 3-way partial replicate study (TRR) is:

❝ TRR

❝ RTR

❝ RRT

❝ […] the CRO chose the following sequences for a 3-way partial rep study; A=Test, B=Ref. A=Test, B=Ref. I dont know why they did this

❝ BAB (RTR)

❝ ABB (TRR)

❝ BBA (RRT)


Are you trying to confuse me? The sequences are the same; the order is irrelevant. Are you not happy with the “A” and “B”? Such a coding would also work:
hocus pocus pocus
pocus hocus pocus
pocus pocus hocus

I guess the sequences were randomized. By chance it might be that the first three subjects had sequences TRR|TRR|TRR. As long as you had ⅓ of subjects allocated to each of the three sequences no problem.

❝ Would scale average BE (SCABE) computation in SAS yield different results if the period and sequence identifier for Ref1 and Ref2 are messed up (ie: CRO inadvertently used the FDA sequences for stats but used their own sequences for dosing)?


Duno what you mean by “FDA sequences”. Of course any administration different from the randomization used in the evaluation would screw up everything. Imagine you have a 2×2×2 cross-over in two (!) subjects. They were dosed (1) RT and (2) TR. Now you assume the sequences were TR and RT. What will you get? ;-)

Can you post the sequences of e.g., the first twelve subjects?

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