Clinical significance of Tmax [Regulatives / Guidelines]
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
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
Complete thread:
- Clinical significance of TmaxM.tareq 2017-10-12 07:53
- Clinical significance of Tmax Helmut 2017-10-12 13:22
- Clinical significance of Tmax M.tareq 2017-10-22 00:36
- Clinical significance of Tmax kumarnaidu 2018-11-01 14:01
- Clinical significance of Tmax Helmut 2017-10-12 13:22