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FDA: antique of ’93 [Regulatives / Guidelines]

posted by Helmut Homepage - Vienna, Austria, 2013-12-11 16:29  - Posting: # 12039
Views: 4,500

Hi John,

» » BTW: Your partial replicate nightmare (#10563). Did you receive an answer from Mr Schuirmann?
»
» Nope. I emailed him two questions and no feedback so far (2nd one was about stats for a partial rep study having 2 groups).

So far? Unbelievable. Ask your legal department to get refund from the FDA for the study you performed exactly following the guidance only to get from SAS:

WARNING: Did not converge.
WARNING: Output 'Estimates' was not created.


Cheers,
Helmut Schütz
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