Risperidone and its metabolite [Design Issues]
Dear All,
Assessment of BE Criteria for risperidone 1mg/1ml oral solution?
as per FDA OGD guidelines analytes to be measure is only risperidone in plasma and 90 % CI for Risperidone.
But Risperidone has its active metabolite 9-hydroxyrisperidone,
my query is for Health canada submission, analytes to be measure both or only parent required? and 90 % CI for ?
kindly share your experience with this molecule.
Regards.
kvgreddy
Assessment of BE Criteria for risperidone 1mg/1ml oral solution?
as per FDA OGD guidelines analytes to be measure is only risperidone in plasma and 90 % CI for Risperidone.
But Risperidone has its active metabolite 9-hydroxyrisperidone,
my query is for Health canada submission, analytes to be measure both or only parent required? and 90 % CI for ?
kindly share your experience with this molecule.
Regards.
kvgreddy
Complete thread:
- Risperidone Cross-over design query Rahul 2008-12-24 06:11
- Risperidone Cross-over design query raghu 2008-12-24 13:00
- Risperidone Cross-over design query ElMaestro 2008-12-25 07:41
- Risperidone and its metabolitekvgreddy06 2014-04-23 09:19
- Risperidone Cross-over design query ElMaestro 2008-12-25 07:41
- Pheno-/genotyping Helmut 2008-12-25 13:44
- Risperidone Cross-over design query raghu 2008-12-24 13:00
