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govardhanpillari ☆ India, 2007-10-09 11:48 (6037 d 01:09 ago) Posting: # 1165 Views: 4,809 |
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Dear HS, How would you conduct/assess Comparative bioavailability of 2 drug products of the same pharamacological category but of different molecules (that is test product is one of the isomer of reference product) and different strengths? Thanks. regards, Gov — Govardhan.P |
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Helmut ★★★   Vienna, Austria, 2007-10-09 17:25 (6036 d 19:32 ago) @ govardhanpillari Posting: # 1167 Views: 3,840 |
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Dear Govardhan, ❝ (... test product is one of the isomer of reference product) and ❝ different strengths? For example 20 mg Esomeprazole (the S-enantiomer) vs 40 mg Omeprazole (the 1:1 racemate)? 1. an enantioselective assay 2. demonstration of no interconversion S <-> R in vivo (possibly based on literature) 3. demonstration of no interconversion during sample preparation in your assay — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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govardhanpillari ☆ India, 2007-10-10 10:54 (6036 d 02:02 ago) (edited by Jaime_R on 2007-10-10 14:08) @ Helmut Posting: # 1169 Views: 3,797 |
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Dear Helmut, Thank u for reply. kindly give the complete details or where i can i get complete guidelines or information for this type of studies. Regards, goardhan. -- Edit: Full quote removed. Please see this post! [Jaime] — Govardhan.P |
Ing. Helmut Schütz