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RegisterWhat’s stated in the protocol? [NCA / SHAM]
Dear Helmut
Thanks for your immediate reply.
A full wash out was considered and in protocol it was stated about Cτ,ss is the concentration at the end of dosing interval in steady state. As the EMEA new guideline for MR product is suggesting for the evaluation of Cτ,ss as one of the primary parameter.
I have read in the forum stating that the requirements as per the new or draft guidelines shall also be addressed to avoid further queries from regulatory at the time of submission. Since there are no time point deviations in sample collection i have to check BE for concentration at 12 hr or 24 hrs on day 6.
Regards,
Murthynaidu
Thanks for your immediate reply.
A full wash out was considered and in protocol it was stated about Cτ,ss is the concentration at the end of dosing interval in steady state. As the EMEA new guideline for MR product is suggesting for the evaluation of Cτ,ss as one of the primary parameter.
I have read in the forum stating that the requirements as per the new or draft guidelines shall also be addressed to avoid further queries from regulatory at the time of submission. Since there are no time point deviations in sample collection i have to check BE for concentration at 12 hr or 24 hrs on day 6.
Regards,
Murthynaidu
Complete thread:
- Regarding the Cτ,ss (Ctau at steady state) calculation murthynaidu 2014-06-20 14:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- What’s stated in the protocol? Helmut 2014-06-20 15:20
- What’s stated in the protocol?murthynaidu 2014-06-20 15:48
- Avoid ambiguities… Helmut 2014-06-20 16:17
- What’s stated in the protocol?murthynaidu 2014-06-20 15:48
- What’s stated in the protocol? Helmut 2014-06-20 15:20
Ing. Helmut Schütz