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What is need to do the steady state studies in BA/BE
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In following cases steady state study is considered appropriate in BA/
(1) Where the drug has long terminal elimination half life and blood
concentration after a single dose cannot be followed for a sufficient
(2) where a assay sensitivity is inadequate to follow the terminal
elimination phase for an adequate period of time.
(3) For drug which are so toxic that ethically they should only be
administered for patients to whom they are a necessary part of
therapy, but where a multiple dose therapy is required, ex: many
(4) For modified release product where it is necessary to access to
the fluctuation in plasma concentration over a dosage interval at
(5) For those drugs which induce their own metabolism or show large
(6) For enteric coated preparation where a coating is innovative.
(7) For combination product where the ratio of plasma concentration of
individual drug is important.
(8) For drug that exhibits non-linear ( i.e dose or time dependent)
(9) Where the drug is likely to accumulate in the body.
In steady state studies the dosing shedule should follow the
clinically recommended dosage regimen.
hope the experts will show their views.
thanks and regards,
GVK Biosciences Pvt. Ltd., (CPU)
7th Floor, Swarnajayanthi Commercial Complex,
Hyderabad - 500 038
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