measurement of active metabolite in european submission [Regulatives / Guidelines]

posted by suchit_bhavsar – India, 2011-07-26 15:49 (5450 d 23:27 ago) – Posting: # 7224
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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

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