cakhatri
★    

India,
2014-02-27 16:23
(3682 d 23:21 ago)

Posting: # 12527
Views: 5,538
 

 Colestipol 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
drgunasakaran1
★★  
avatar

2014-03-01 06:55
(3681 d 08:49 ago)

@ cakhatri
Posting: # 12537
Views: 5,192
 

 Colestipol BE study design

Dear Mr Chirag,

You need to follow FDA individual product bioequivalence guidance of Cholestyramine or Colesevelam Hydrochloride for designing the study for Colestipol.

In FDA published "In vitro binding bioequivalence study summary tables and SAS transport formatted tables for dataset submission for Colestipol", they have mentioned the In-vitro equilibrium binding study and In-vitro kinetic binding study similar to Cholestyramine and Colesevelam.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
cakhatri
★    

India,
2014-03-01 14:15
(3681 d 01:28 ago)

@ drgunasakaran1
Posting: # 12539
Views: 4,649
 

 Colestipol BE study design

Dear Dr.Gunasekaran,
Many thanks for your response and the link to the FDA document.
Regards
Chirag
MGR
★    

India,
2015-07-24 16:25
(3171 d 00:18 ago)

@ cakhatri
Posting: # 15143
Views: 3,795
 

 Colestipol BE study design

Dear All,

Could anyone has done this type of analysis in SAS, if so could you please provide me the references to calculate the k1 and k2.

Thanks in advance,

Regards,
MGR
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