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RegisterRevised Imatinib Mesylate Tablets OGD by FDA [Design Issues]
Only logical explanation: Mistake in the guidance or semantic issues
Is there any way to find out if this is the case?
How could it be ' a single dose' when patients are already on the medication (considering the fact that Cmax might still be not far at the time of the single dosing)?
A wash-out would be unethical and in the end we would have to use Steady State parameters for the BE anyway.
Is there any way to find out if this is the case?
How could it be ' a single dose' when patients are already on the medication (considering the fact that Cmax might still be not far at the time of the single dosing)?
A wash-out would be unethical and in the end we would have to use Steady State parameters for the BE anyway.
Complete thread:
- Revised Imatinib Mesylate Tablets OGD by FDA shaanthi_4u 2013-04-16 07:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Revised Imatinib Mesylate Tablets OGD by FDA shaanthi_4u 2013-04-22 08:19
- Revised Imatinib Mesylate Tablets OGD by FDA jodywood 2013-08-14 08:47
- Revised Imatinib Mesylate Tablets OGD by FDAcloudmember 2013-08-29 15:25
Ing. Helmut Schütz