Critical dose drugs - FDA highly variable NTID [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2017-04-25 10:41 (2850 d 21:43 ago) – Posting: # 17260
Views: 3,541

Dear Nirav,

again: If you aimed a submission in Canada follow my hint.

What you cite as "OGD for rivaroxaban" is FDA recommended evaluation method. Follow it if you aim for an FDA submission.

If you aim for an EMA submission follow the EMA recommendations.

Other regulatory bodies may have different recommendations. Follow them if you aim for a submission to them.

Simple. Isn't it?

Regards,

Detlew

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