Postmenopausal women [Regulatives / Guidelines]

posted by Mauricio Sampaio  – Brazil, 2016-02-12 04:24 (3290 d 23:28 ago) – Posting: # 15979
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Dear Dan,

❝ I tested oral contraceptives in men and it was accepted by FDA and EMA.


the assay was regulatory submission or an exploratory test?
Without any doubt of your information, but is there a public assessment document from FDA and EMA?

In ANVISA guidelines is described: If the drug is indicated for patients with specific characteristics of age and sex, the study should be fully performing in volunteers with these characteristics. I think that nobody male will talk with thin voice after a single dose of estradiol, .... but is black on white!

FDA do not the same position? See link:Product-Specific Recommendations

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