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RegisterType of study in modified release formulation EMEA [Regulatives / Guidelines]
Dear All,
We would like to submit dossier of generic modified release formulation in Europe and we are not cleared about following statement of guideline.
The European guidance line no. 593 to 595 states as follows:
"A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected".
In this if you read they are asking to see AUC(0-τ) after single dose which confuse us as after single dose administration how this parameter can be evaluated. I think here to cases are cubed which ultimately resulting into the confusion.
with addition to this the entire section is not delivering correct understanding to me hence if possible can any one make it simple it to get optimum understanding.
regards,
Compliance
Edit: In 2005 (!) EMEA (European Agency for the Evaluation of Medicinal Products) lost its second E and was renamed to EMA (European Medicines Agency).
[Helmut]
We would like to submit dossier of generic modified release formulation in Europe and we are not cleared about following statement of guideline.
The European guidance line no. 593 to 595 states as follows:
"A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected".
In this if you read they are asking to see AUC(0-τ) after single dose which confuse us as after single dose administration how this parameter can be evaluated. I think here to cases are cubed which ultimately resulting into the confusion.
with addition to this the entire section is not delivering correct understanding to me hence if possible can any one make it simple it to get optimum understanding.
regards,
Compliance
Edit: In 2005 (!) EMEA (European Agency for the Evaluation of Medicinal Products) lost its second E and was renamed to EMA (European Medicines Agency).
[Helmut]Complete thread:
- Type of study in modified release formulation EMEACompliance 2014-03-13 09:43 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Type of study in modified release formulation EMEA nobody 2014-03-13 09:52
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- Scaling of Cmin d_labes 2014-12-11 13:09
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- Scaling of Cmin VStus 2017-02-03 13:04
- Scaling of Cmin zizou 2017-02-03 13:49
- Scaling of Cmin VStus 2017-02-03 15:37
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- Scaling of Cmin zizou 2017-02-03 13:49
- Scaling of Cmin VStus 2017-02-03 13:04
- Scaling of Cmin Helmut 2014-12-11 14:53
- Scaling of Cmin d_labes 2014-12-11 13:09
- Scaling of Cmin Helmut 2014-12-10 18:40
- Steady state kumarnaidu 2014-12-10 11:15
- Scaling of Cmin Helmut 2014-11-27 13:47
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 12:53
- Type of study in modified release formulation EMEA nobody 2014-11-27 11:37
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 11:02
Ing. Helmut Schütz