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RegisterAlendronate: which country? [Design Issues]
Regarding the use of plasma or urine, originally it was not possible to analyze the plasma levels due to sensivitiy issues for bisphosphonates. However labs now have the sensitivity to analyze plasma PK profiles. Last year I discussed with FDA why for alendronate it is recommended to analyze in urine when plasma is available. The response was that it is an old recommendation, and that if plasma PK analysis is possible, then this should be used.
My lab currently has a method for both plasma and urine analysis, however as of now, sponsors have only used the urine method.
My lab currently has a method for both plasma and urine analysis, however as of now, sponsors have only used the urine method.
Complete thread:
- Design of Alendronate sodium raghavendra_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