Nicergoline [Regulatives / Guidelines]
Dear Dan
Thank you very much for your response.
In case of nicergoline, we found data that revealed that nicergoline undergoes an important first - pass effect and can not be detected in plasma samples. Therefore, I am planning to use both metabolites.
From my experience, the metabolite data is used only as supportive data.
This is the reason for my question (and I hope that my question is corect)
In case of analysis of more than one metabolite, the bioequivalence criteria must be met by all metabolites? (now is the case of nicergoline, but also is a theoretical question)
Thank you
Ioana
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Thank you very much for your response.
In case of nicergoline, we found data that revealed that nicergoline undergoes an important first - pass effect and can not be detected in plasma samples. Therefore, I am planning to use both metabolites.
From my experience, the metabolite data is used only as supportive data.
This is the reason for my question (and I hope that my question is corect)
In case of analysis of more than one metabolite, the bioequivalence criteria must be met by all metabolites? (now is the case of nicergoline, but also is a theoretical question)
Thank you
Ioana
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- Nicergoline ioanam 2013-09-07 21:55
- Nicergoline Dr_Dan 2013-09-09 10:15
- Nicergolineioanam 2013-09-10 14:42
- Nicergoline Dr_Dan 2013-09-09 10:15
