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cakhatri ★ India, 2014-02-27 16:23 (3704 d 01:37 ago) Posting: # 12527 Views: 5,595 |
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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 |
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drgunasakaran1 ★★  2014-03-01 06:55 (3702 d 11:05 ago) @ cakhatri Posting: # 12537 Views: 5,240 |
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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. |
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cakhatri ★ India, 2014-03-01 14:15 (3702 d 03:44 ago) @ drgunasakaran1 Posting: # 12539 Views: 4,697 |
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Dear Dr.Gunasekaran, Many thanks for your response and the link to the FDA document. Regards Chirag |
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MGR ★ India, 2015-07-24 16:25 (3192 d 02:34 ago) @ cakhatri Posting: # 15143 Views: 3,843 |
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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 |
Ing. Helmut Schütz