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vatsalasinha ● 2009-02-17 13:45 (6333 d 20:26 ago) Posting: # 3259 Views: 3,601 |
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Hi Friends, I have a query regarding the dosage of the reference and the test product. If the BE is done as per the therapeutic dosage but the plasma levels could not be detected due to very low plasma levels of the drug, then in that case can the dose be doubled for the convenience of detetection of the drug in plasma to prove the Bioequivalence? Please let me know how logical is this? Thanks and Regards Dr.Vatsala Sinha |
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Helmut ★★★   Vienna, Austria, 2009-02-17 15:10 (6333 d 19:01 ago) @ vatsalasinha Posting: # 3261 Views: 2,821 |
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Dear Vatsala! ❝ If the BE is done as per the therapeutic dosage but the plasma levels could not be detected due to very low plasma levels of the drug, then in that case can the dose be doubled for the convenience of detetection of the drug in plasma to prove the Bioequivalence? Do I get you right: you want to go with the dosage beyond the therapeutic dosage? IMHO no way. — 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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vatsalasinha ● 2009-02-20 06:03 (6331 d 04:08 ago) @ Helmut Posting: # 3280 Views: 2,867 |
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Hey Thanks for the response!!! But further to my previous query, what if after doubling the dose also the dose is still in the therapeutic range! Can that be considered for proving the bio-equivalence? To be more clear, recently I saw one BE report where a particular drug was proved to be equivalent to the reference. Here the actual recommended dose is 1 tablet morning and evening. But since the Plasma levels could not be detected properly in plasma for analysis, the investigator decided to make it as a double dose study. The subjects were given two tablets stat of both reference and test. Just to inform you that even the two tablets are in therapeutic range and are considered very safe for human subjects as the drug is uptitrated to doses much beyond two tablets stat. My only concern is that does it stand true that if they have proven that two tablets of Reference is bioequivalent to two tablets of the test, then it means that 1 tablet of reference is equivalent to 1 tablet of test? Just to make it more clear, in this particular case the F2 factor is not applicable for this particular drug after the dissolution test. -- Edit: Moved to previous thread. [Helmut] |
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Prashanth ☆ 2009-02-19 14:15 (6331 d 19:56 ago) @ vatsalasinha Posting: # 3276 Views: 2,840 |
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Hi Dr Vatsala, Instead of plasma analysis, I think we can go urine analysis/serum analysis based on the ADME of the drug. I think the concentration taken for the analysis is not properly validated. — Best Regards, Prashanth |
Ing. Helmut Schütz