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RegisterMDIs formulation [Regulatives / Guidelines]
Hi Mahesh M,
I don't.
I think it is a rather practical matter.
Yes, you can e.g. write in your protocol that you are dosing approx. 30 secs apart and that t=0 is when the first puff is given.
By the way you don't always need to do everything strictly as per SPC for EU submissions. Other examples of SPC deviations in OIP studies include nose clips and total doses.
Good luck with your study.
❝ do you have any reference for the same?
I don't.
I think it is a rather practical matter.
❝ We have to mention dosing procedure in protocol and if we not mention about 30 sec gap between two puffs, regulatory agency may ask for the same (means not follow the SPC with regards of dosing instruction)
Yes, you can e.g. write in your protocol that you are dosing approx. 30 secs apart and that t=0 is when the first puff is given.
By the way you don't always need to do everything strictly as per SPC for EU submissions. Other examples of SPC deviations in OIP studies include nose clips and total doses.
Good luck with your study.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- MDIs formulation Mahesh M 2014-12-11 13:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- MDIs formulation ElMaestro 2014-12-11 13:54
- MDIs formulation Mahesh M 2014-12-12 06:57
- MDIs formulationElMaestro 2014-12-12 09:36
- MDIs formulation Mahesh M 2014-12-12 06:57
- MDIs formulation ElMaestro 2014-12-11 13:54
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