Polymorphism BE [Dissolution / BCS / IVIVC]
Dear Ace
IMHO your idea sounds reasonable. But please be advised: First of all you need to know if the originator product shows the same polymorphism. If the originator product is also a mixture of polymorph B with approximately 80% and polymorph A with approximately 20% and if you can demonstrate for the originator product that the polymorph A converts into polymorph B in the same way then you have some strong arguments. If the originator product is a different mixture of polymorph B and polymorph A you need to show if the polymorphs are effective in the same way. Otherwise you have a problem.
I hope this helps
Kind regards
Dan
IMHO your idea sounds reasonable. But please be advised: First of all you need to know if the originator product shows the same polymorphism. If the originator product is also a mixture of polymorph B with approximately 80% and polymorph A with approximately 20% and if you can demonstrate for the originator product that the polymorph A converts into polymorph B in the same way then you have some strong arguments. If the originator product is a different mixture of polymorph B and polymorph A you need to show if the polymorphs are effective in the same way. Otherwise you have a problem.
I hope this helps
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Polymorphism BE Aceto81 2011-11-23 14:09 [Dissolution / BCS / IVIVC]
- Polymorphism BEDr_Dan 2011-11-24 10:30
