Baseline correction examples [Regulatives / Guidelines]

posted by Lucas – Brazil, 2016-02-10 12:48 (3286 d 16:58 ago) – Posting: # 15969
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Hi Mauricio!

The issue with that, at least here in Brazil, is recruiting post-menopause healthy subjects. We see a lot of failed pre study exams results like cholesterol, BMI out of range, etc. So it is not that easy to recruit these women, usually taking a lot of extra time in recruitment and screening. But it would be far more easy to conduct BE studies of female hormones with them, and at least ANVISA accepts it so far. I wouldn't know about FDA and EMA, but I think that they'd accept as well. Baseline levels of estradiol are a nightmare in healthy fertile women...

Regards

Lucas

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