Donepezil SR 23 mg Tablets BE study [Study Per­for­mance]

posted by madhavaraob – 2010-07-07 09:27 (5481 d 10:26 ago) – Posting: # 5597
Views: 13,117

Dear all,

We are planning to conduct a bioequivalence study on Donepezil SR 23 mg tablets in comparision with 10 mg IR tablets for US regulatory. We would like to know whether this study is feasible to be conducted in healthy population or in patients?
If the study need to be conducted in patients, what is the severity of the diseased condition (mild/moderate/severe) to be selected?

With Regards,

Madhav

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