Clinical significance of Tmax [Regulatives / Guidelines]

posted by M.tareq  – 2017-10-12 05:53  – Posting: # 17890
Views: 2,937

Dear all ,

I have a question about Tmax from clinical perspective.

According to EMA guidance:
"A statistical evaluation of tmax is not required. However, if rapid release is claimed to be clinically relevant and of importance for onset of action or is related to adverse events, there should be no apparent difference in median tmax and its variability between test and reference product."

If a fast disintegrating tab has a tmax earlier than the conventional release, does it prove that it has an earlier onset of action?

Thanks in advance and Best regards

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