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Dear all,
I hope someone has experience and some spare time for this topic.
When to do a steady state study? Not from regulatory point of view
but from scientific point.
What PK characteristics should this molecule (or product) have to be
candidate for steady state.
Whit regards,
Lidija
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Dear Lidija,
I suggest you look at the recommended dosing pattern, tmax, Cmax,
half-life and elimination kinetics. In the trials that I have been
part of, the steady state has occured in about 5 days, but this will
definitely differ from molecule to molecule. Its difficult for me to
comment without knowing the above mentioned parameters.
Regards,
Dr. Gagandeep Singh
Senior Consultant
Domain Consulting Team - Lifesciences
Cognizant Technology Solutions
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