PharmPK Discussion - Clinical Study of API and its active metabolite

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On 16 Apr 2011 at 19:53:49, satyajeet narode (satyajeet0407.at.gmail.com) sent the message


Dear All

I want to make SR tablets and do clinical study. But metabolite of drug  is also having the therapeutic action. Half life to drug is 4-5 hrs and  that of metabolite is 10 hrs.

What are things to be considered when developing such kind of dosage  forms? In clinical study it will show 2 AUC for active and its  metabolite.so how its compared with invitro data?

Regards
Satyajeet

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