Bioequivalence and Bioavailability Forum • Deficiency centers

Deficiency centers [Design Issues]

posted by Helmut – Vienna, Austria, 2009-12-17 16:52 (6036 d 03:39 ago) – Posting: # 4496
Views: 6,758

Dear D. Labes,

❝ If I understand you right you suggest me to do the usual evaluation

❝ (ignoring the centers) and to wait for a deficiency letter?

First part: yes, second part: no.
OK, all of us are waiting for deficiency letters all the time. So it doesn't make a difference here. :lol3:

❝ And if it happens (low chance) then answer "Due to the identical protocol,

❝ due to the identical handling of blood samples, central assay of the blood

❝ samples, blah, blah ... no influence of the different centers was expected

❝ at all."? Eventually this could/should be included in the study report

❝ beforehand.

I would suggest to write the "blahblah" in the study protocol (not the report).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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