Dose based on m² [General Sta­tis­tics]

posted by VK – Russia, 2013-07-17 12:35 (3719 d 14:26 ago) – Posting: # 10991
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Dear HS and colleagues,

I am a newcomer, I work in BE bioanalytics lab in BRIC country (right btw Brazil and India). We recently had a BE project (single dose, two-way crossover) with a cytostatic which is prescribed based on body surface area. Thus c.a. 70% of the sample size received Х mg of either R/T in each period, while 30% received 0.75Х mg or 1.25Х mg.
We did regular calculations however authorities require different approach. They want us to use only X mg data for statistical evaluation, saying that we cannot use 30% because of the different dose.
I am currently trying to think of argumentation persuading authorities to accept calculations based on the whole data set. Unfortunately I cannot refer to common sense and basic statistical considerations that is why I need more like a reference to a GL or an article. I would greatly appreciate if you could help me with few references if any.


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