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RegisterDoubling the dose but in therapeutic range itself [Bioanalytics]
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.
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Edit: Moved to previous thread. [Helmut]
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.
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Edit: Moved to previous thread. [Helmut]
Complete thread:
- Can the dose be doubled? vatsalasinha 2009-02-17 12:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- dose > therapeutic dosage? Helmut 2009-02-17 14:10
- Doubling the dose but in therapeutic range itselfvatsalasinha 2009-02-20 05:03
- Can the dose be doubled? Prashanth 2009-02-19 13:15
- dose > therapeutic dosage? Helmut 2009-02-17 14:10
Ing. Helmut Schütz