Log in
Registerorally inhaled products (OIPs) [Regulatives / Guidelines]
Hi Mahesh M,
in case you are submitting in an area relying on the EU guidance then yes, you can sometimes study one strength in a in vivo study and get the other strengths for free via in vitro data. You can sometimes even get all strengths via in vitro studies.
Here's a link to the presently enforced guideline.
But be careful. Companies fail and fail and fail when they try to develop according to this guideline.
in case you are submitting in an area relying on the EU guidance then yes, you can sometimes study one strength in a in vivo study and get the other strengths for free via in vitro data. You can sometimes even get all strengths via in vitro studies.
Here's a link to the presently enforced guideline.
But be careful. Companies fail and fail and fail when they try to develop according to this guideline.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- orally inhaled products (OIPs) Mahesh M 2014-12-03 13:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- orally inhaled products (OIPs) drgunasakaran1 2014-12-03 15:13
- orally inhaled products (OIPs)ElMaestro 2014-12-03 15:45
- orally inhaled products (OIPs) Mahesh M 2014-12-04 13:52
- orally inhaled products (OIPs) ElMaestro 2014-12-04 15:40
- orally inhaled products (OIPs) Mahesh M 2014-12-04 13:52
Ing. Helmut Schütz