Bioequivalence and Bioavailability Forum

Hi Mr. Rao,

now you sound like a banker or a LEAN consultant
I don't know how those terms fit into the realm of regulated BE.

Why would a bioanalyst have access to the rand. code after all? I think there should be a reason; preferably a better reason than just convenience. Of course, from a regulatory side there might arise a bit of fear that knowledge pf the rand. code could be used inappropriately somehow: As far as I can tell a bioanalyst knowing the rand. code can use that knowledge inappropriately during the analysis phase (without going into detail, mind you), and coversely I don't see how the knowledge can be used in a good fashion. If you ever find yourself in a situation where people question the integrity of a study then you are better off if you can demonstrate that the QMS is mature and that the rand. code is not accessible or accessed until the day of stats.