measurement of active metabolite in european submission [Regulatives / Guidelines]
Hello to All,
For europian submission, if parent compound is measurable and can be subjected for bioequivalence.
Does it required to present active metabolite data as a supportive evidence for bioequivalence ?
Thanks and regards,
Suchit Bhavsar
For europian submission, if parent compound is measurable and can be subjected for bioequivalence.
Does it required to present active metabolite data as a supportive evidence for bioequivalence ?
Thanks and regards,
Suchit Bhavsar
Complete thread:
- measurement of active metabolite in european submissionsuchit_bhavsar 2011-07-26 13:49
- If possible, parent only Helmut 2011-07-26 14:23
