Missing periods in replicate designs: save the data? [RSABE / ABEL]

posted by Astea – Russia, 2019-10-20 14:46  – Posting: # 20709
Views: 724

Dear smart people!

I've got two questions on this topic, that could be logically combined into the one philosophical: should we try to keep as much data as possible for the analysis?

1). How would you advice to deal with subjects, who have only one (2,3..) points over LLOQ in one of the periods? According to EMA it is possible to exclude subjects with AUC of reference product less than 5% of geometric mean AUC. Should we exclude all the data of such a subject or can we remain data from other periods?
Example: acetylcalycic acid (ASA) in enteric-coated form has a wide-range Tmax in about 2 to 7 hours with extremely rapid conversion to salycic acid. So PK profiles look like "zero-zero-vertical line-zero-zero"... For catching it one has to plan a great number of sample points and use appropriate stabilization procedure. Even in these case there could be the uppermentioned problems.


2). What was the real reason for FDA to develop an algorithm for NTIDs with only complete data? As Helmut mentioned in the post, theoretically it is possible to use all the data even with incomplete data. Why then FDA just throw data of subjects with incomplete data to the bin? Is not it unethical? (I can't understand this point)

"We are such stuff as dreams are made on, and our little life, is rounded with a sleep"

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