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RegisterAlendronate Urine PK [PK / PD]
Hi All;
We did alendronate BE in urine on 56 subjects, but ended up with one or two missing urine samples in about 28 subjects in test and/or refernce.
Hence, the comulative amount excreted (Ae) wont be accurate in those 28 subjects due to lost drug samples.
What to do
: delete 28 subjects from the study or assume that the lost drug is random among test and reference, and do calculations of Ae as usual?
Unfourtunately current US FDA guideline did not help since it asks for BE in plasma.
Thanks for your guidance.
We did alendronate BE in urine on 56 subjects, but ended up with one or two missing urine samples in about 28 subjects in test and/or refernce.
Hence, the comulative amount excreted (Ae) wont be accurate in those 28 subjects due to lost drug samples.
What to do
: delete 28 subjects from the study or assume that the lost drug is random among test and reference, and do calculations of Ae as usual?Unfourtunately current US FDA guideline did not help since it asks for BE in plasma.
Thanks for your guidance.
Complete thread:
- Alendronate Urine PKnasir 2013-09-17 22:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Alendronate Urine PK Helmut 2013-09-17 22:35
- Alendronate Urine PK nasir 2013-09-18 08:11
- Alendronate Urine PK Dr_Dan 2013-09-18 09:22
- Alendronate Urine PK nasir 2013-09-18 10:08
- Alendronate Urine PK Dr_Dan 2013-09-18 09:22
- Alendronate Urine PK nasir 2013-09-18 08:11
- Alendronate Urine PK Helmut 2013-09-17 22:35
Ing. Helmut Schütz