Baseline correction examples [Regulatives / Guidelines]

posted by Mauricio Sampaio  – Brazil, 2016-02-11 02:38 (3427 d 22:02 ago) – Posting: # 15973
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Hi Lucas

❝ So it is not that easy to recruit these women, usually taking a lot of extra time in recruitment and screening


I share of same situation explained by Helmut. "Recruitment was tricky in the beginning but after a while we had a nice pool in our volunteers database".

We performed two studies with Estradiol in postmenopausal women for Brazilian submission. One fail and one success! In my opnion your bad result was in part from formulation and/or in part from analytical phase (Main point! Wary!!!!!).

❝ I wouldn't know about FDA and EMA, but I think that they'd accept as well.


Look:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM238055

Regards

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