The following message was posted to: PharmPKBack to the Top
We are a scientific group currently working on the Bioequivalence
study of Omeprazole for a generic pharmaceutical company. Omeprazole
delayed release capsules are available as 20 mg and 40 mg Strengths
and as the innovator has submitted two NDA's on separate strengths it
has been asked by FDA to submit separate BE studies for 20 mg and 40
mg capsules even if the are dose proportionally scaled up. With the
recent changes in USFDA requirements on bioequivalence studies from
October 2000, it is implied that when 40 mg capsules are
bioequivalent, waiver for 20 mg capsule can be granted. Looking at
the cost implications and etical consideration of administration of
drugs to healthy humans, is it necessary to carryout separate
bioequivalence studies for 20 and 40 mg Capsules? or Is it sufficient
to prove the bioequivalency of 40 mg and apply for and comply with
waiver requirements (i.e., dose proportionality and invitro release
data). Expert opinion and waiver application procedure in this regard
are sought through this forum.
The following message was posted to: PharmPKBack to the Top
Just do the BE study for 40 mg and apply for the waiver for the 20 mg
if the 20 mg has proportional ingredients in the formulation.
Lydia Kaus
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