Type of study in modified release formulation EMEA [Regulatives / Guidelines]
❝ "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".
This does not seem so cryptic anyway...
Let's assume a once daily dosing is the standard regimen for the originator (reference) product.
You have to perform a BE single dose study with both test and reference formulations at the highest registered strength and compute AUC0-24h and AUC0-inf. If this study demonstrate that AUC0-24h > 0.9 × AUC0-inf for both test and reference, it is not necessary to perform a MD BE study.
Hope this helps.
—
Kind regards,
Fabrice
Kind regards,
Fabrice
Complete thread:
- Type of study in modified release formulation EMEA Compliance 2014-03-13 09:43 [Regulatives / Guidelines]
- Type of study in modified release formulation EMEA nobody 2014-03-13 09:52
- Type of study in modified release formulation EMEAfno 2014-03-13 11:16
- Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 11:02
- Type of study in modified release formulation EMEA nobody 2014-11-27 11:37
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- Scaling of Cmin Helmut 2014-11-27 13:47
- Scaling of Cmin kumarnaidu 2014-11-27 15:12
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- Steady state kumarnaidu 2014-12-10 11:15
- Steady state nobody 2014-12-10 17:04
- Scaling of Cmin Dr_Dan 2014-12-10 17:21
- Scaling of Cmin Helmut 2014-12-10 18:40
- Scaling of Cmin d_labes 2014-12-11 13:09
- Scaling of Cmin Helmut 2014-12-11 14:53
- 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
- Scaling of Cmin VStus 2017-02-06 08:55
- 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