Risperidone and its metabolite [Design Issues]

posted by kvgreddy06 – India, 2014-04-23 11:19 (4441 d 01:45 ago) – Posting: # 12874
Views: 4,424

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

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