Postmenopausal women [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2016-02-15 18:45 (2964 d 05:04 ago) – Posting: # 15991
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Dear Mauricio,

❝ the assay was regulatory submission or an exploratory test?


Pivotal studies to get MA for a generic product

❝ 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.


As I said if you regard BE as an in-vivo quality test of your formulation you do not need to reflect clinical use especially with regard to specific characteristics of age and sex. In former times FDA agreed with this approach but I have to admit that in the meantime they revised their product specific recommendations.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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