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RegisterDesign of Alendronate sodium [Design Issues]
Dear Madam/Sir,
I would like to know the issues involved in the design of Alendronate sodium for two treatment, two period, two sequence, single dose, crossover bioequivalence study.
Please clarify me the issues associated with sampling (plasma/serum or urine)? which one is best to quantify the drug, serum/plasma or urine? How it impact the study design?
In the published literature, the number of volunteers too largely vary from one article to another. How much sample size is required? statistical parameters etc. What is the washout period for this study ?
It seems only HPLC-Fluorescence detection technique is available for estimation of the drug. Is there any updates on analytical developments of this drug in serum?
Any discussion on further updates, technical aspects on this study design is highly appreciated?
Kind regards,
I would like to know the issues involved in the design of Alendronate sodium for two treatment, two period, two sequence, single dose, crossover bioequivalence study.
Please clarify me the issues associated with sampling (plasma/serum or urine)? which one is best to quantify the drug, serum/plasma or urine? How it impact the study design?
In the published literature, the number of volunteers too largely vary from one article to another. How much sample size is required? statistical parameters etc. What is the washout period for this study ?
It seems only HPLC-Fluorescence detection technique is available for estimation of the drug. Is there any updates on analytical developments of this drug in serum?
Any discussion on further updates, technical aspects on this study design is highly appreciated?
Kind regards,
Complete thread:
- Design of Alendronate sodiumraghavendra_s 2010-05-12 11:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Alendronate: which country? Helmut 2010-05-12 15:38
- Alendronate: which country? raghavendra_s 2010-05-12 17:06
- Alendronate: which country? jchapdelaine 2010-05-12 22:16
- Alendronate: which country? raghavendra_s 2010-05-12 17:06
- Alendronate: which country? Helmut 2010-05-12 15:38
Ing. Helmut Schütz