Log in
Registermultiple dosage study [Regulatives / Guidelines]
Dear All,
For EMA submission of prolonged release dosage form is it possible to Waiver for multiple dosage study on the basis of evidence of “lack of accumulation (by SPC, PAR or literature) and the provide partial AUC for both fasting and fed two way study as supportive?
Regards
For EMA submission of prolonged release dosage form is it possible to Waiver for multiple dosage study on the basis of evidence of “lack of accumulation (by SPC, PAR or literature) and the provide partial AUC for both fasting and fed two way study as supportive?
Regards
Complete thread:
- multiple dosage studyMahesh M 2016-08-18 12:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- multiple dosage study VStus 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 study VStus 2016-08-24 21:37
Ing. Helmut Schütz