What is the point of IVIVCs for generics? [Dissolution / BCS / IVIVC]
Hi Dr. Dan,
IVIVC is applicable for a generic company in terms formulation development, post pilot bio-study formulation optimization (ie: if established, the model allows you to predict a target disso profile which can result in a product BE to reference).
Of course then you have specification, site transfer, stability, yada yada...
John
IVIVC is applicable for a generic company in terms formulation development, post pilot bio-study formulation optimization (ie: if established, the model allows you to predict a target disso profile which can result in a product BE to reference).
Of course then you have specification, site transfer, stability, yada yada...
John
Complete thread:
- What is the point of IVIVCs for generics? CLR 2016-04-11 10:12 [Dissolution / BCS / IVIVC]
- What is the point of IVIVCs for generics? jag009 2016-04-12 16:24
- What is the point of IVIVCs for generics? CLR 2016-04-19 05:29
- What is the point of IVIVCs for generics? luvblooms 2016-04-19 16:43
- What is the point of IVIVCs for generics? Dr_Dan 2016-04-20 14:17
- Education needed Helmut 2016-04-20 16:04
- What is the point of IVIVCs for generics?jag009 2016-04-20 21:29
- What is the point of IVIVCs for generics? Dr_Dan 2016-04-21 08:35
- What is the point of IVIVCs for generics? Dr_Dan 2016-04-20 14:17
- What is the point of IVIVCs for generics? jag009 2016-04-12 16:24