Regulations ≠ Science [Regulatives / Guidelines]

posted by DavidManteigas – Portugal, 2017-04-04 14:04 (2873 d 22:00 ago) – Posting: # 17226
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@nobody

You would be surprised if you attended a primary care consultation in Portugal :-D

In my experience, physicians only know one thing about pharmacokinetics: the medicine half-life. Now, imagine when we start to talk about bioequivalence, AUC and stuff like that. They simply don't have the necessary knowledge to understand the concept of bioequivalence. The common wisdow (should be read "Medical Information Delegate" or more recently "Medical Science Liasion") is that generics are a lot different from innovators (there is always one history of some old lady who switched from innovator to gene­ric and the generic was not as effective as the innovator). What happens frequently is that the patients asks for generics regardless of the opinion of the physician.

In my opinion, after looking at so many concentration data from bioequivalence studies and the huge inter-subject variability associated, I don't believe that using a generic or innovator makes any difference in the therapeutic effect when compared with the diet or other extrinsic factors. The API is the same and in the same amount (with some variation, of course) so I can't understand what is the mistrust the medical community have with the generics other than information manipulation from industry.

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