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RegisterColestipol BE study design [Design Issues]
Dear Members,
We have a requirement for conduct of BE study on Colestipol tablets for USFDA submission. There is no BE recommendation from FDA and no reference literature is available through which the design can be concluded. Upon review of the literature, the indication seems to be similar to Cholestyramine, for which FDA has guideline for conduct of in-vitro equilibrium binding study and in-vitro kinetic study
Can the same be applied to Colestipol, or can anyone share their experience with Colestipol
Best Regards
Chirag
We have a requirement for conduct of BE study on Colestipol tablets for USFDA submission. There is no BE recommendation from FDA and no reference literature is available through which the design can be concluded. Upon review of the literature, the indication seems to be similar to Cholestyramine, for which FDA has guideline for conduct of in-vitro equilibrium binding study and in-vitro kinetic study
Can the same be applied to Colestipol, or can anyone share their experience with Colestipol
Best Regards
Chirag
Complete thread:
- Colestipol BE study designcakhatri 2014-02-27 15:23
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- Colestipol BE study design drgunasakaran1 2014-03-01 05:55
- Colestipol BE study design cakhatri 2014-03-01 13:15
- Colestipol BE study design MGR 2015-07-24 14:25
- Colestipol BE study design cakhatri 2014-03-01 13:15
- Colestipol BE study design drgunasakaran1 2014-03-01 05:55
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