BE study designs [Design Issues]

posted by shiv – 2006-01-25 07:46 (7444 d 12:52 ago) – Posting: # 61
Views: 33,752

Hello Helmut

I am shiv. I quite impressed for your inputs on study design. I would like to update on ANVISA approval process.

Initially ANVISA approval is for the facility and after approval only we have to conduct the studies. Please update us the current process is it pre approval or post study approval.

Regards
shiv prasad

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