Log in
Registerimpact of excipients [Dissolution / BCS / IVIVC]
Dear Dan
Agree to your point that there are
And yes they cause confusion too.
Now coming to your point
How about doing reverse engineering? Try using NIR or some other method (some time chemical methods works too) to estimate the excipient quantitatively.
We have done it for one of the BCS class I drug for US and EU submission and did not faced much problem. (In that condition reference was having poloxamer and different amounts for US and EU, quantitative estimations helped)
Agree to your point that there are
❝ an endless number of papers describing an impact of an excipient on a special drug substance.
And yes they cause confusion too.
Now coming to your point
❝ you do not know the exact quantitative composition of the reference and how to decide which difference would become significant and relevant?
How about doing reverse engineering? Try using NIR or some other method (some time chemical methods works too) to estimate the excipient quantitatively.
We have done it for one of the BCS class I drug for US and EU submission and did not faced much problem. (In that condition reference was having poloxamer and different amounts for US and EU, quantitative estimations helped)
—
~A happy Soul~
~A happy Soul~
Complete thread:
- impact of excipients Dr_Dan 2013-09-27 12:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- impact of excipients jag009 2013-09-27 21:44
- impact of excipients luvblooms 2013-09-30 06:29
- impact of excipients Dr_Dan 2013-10-02 10:12
- impact of excipientsluvblooms 2013-10-03 05:53
- impact of excipients Dr_Dan 2013-10-02 10:12
Ing. Helmut Schütz