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Registermultiple dosage study [Regulatives / Guidelines]
Hi Mahesh,
On my opinion, it's clearly stated that SPC, PAR or literature is not sufficient as both Test and Reference product's data are required:
6.1.1.2. Multiple dose studies
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-tau) 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.
Best regards,
VStus
❝ “lack of accumulation" (by SPC, PAR or literature) and the provide partial AUC for both fasting and fed two way study as supportive data.
On my opinion, it's clearly stated that SPC, PAR or literature is not sufficient as both Test and Reference product's data are required:
6.1.1.2. Multiple dose studies
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-tau) 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.
Best regards,
VStus
Complete thread:
- multiple dosage study Mahesh M 2016-08-18 12:50 [Regulatives / Guidelines]
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- multiple dosage studyVStus 2016-08-24 21:37
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage study VStus 2016-08-25 18:34
- multiple dosage study BE-proff 2016-08-26 10:45
- τ in SD = intended dosage interval Helmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-26 14:17
- Some questions from EGA regarding MR Guideline mittyri 2016-08-26 17:43
- Quod licet Iovi, non licet bovi Helmut 2016-08-26 19:42
- τ in SD = intended dosage interval Helmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage studyVStus 2016-08-24 21:37
Ing. Helmut Schütz