THe BIOWaIVer MONOGraPHS - FIP

levels are set at 90% and the power level at 80% in in vivo studies, it is clear that
reaching an inappropriate decision in an in vivo bioequivalence study is also possible,
but is statistically definable. One approach to determining the acceptable risk for an
inappropriate biowaiver decision would be to set it at the same level as an acceptable
risk for a false decision made on the basis of an in vivo bioequivalence study.
In the future it is to be hoped that this risk calculation (risk of an incorrect
bioequivalence decision based on the BCS biowaiver) can be put on a more formal basis
and applied in a consistent way in the conclusions of the Biowaiver Monographs.
Of course, the ramifications of an incorrect biowaiver decision (such that a
suprabioequivalent or subbioequivalent product enters the market) are highly
dependent on the indication and therapeutic index of the drug. Thus, these risks need
to be assessed on an individual drug basis.
Global Harmonization of Biowaiver Regulations
Perhaps most importantly, and in the interests of consistent global health policies,
a key future activity in the BCS based biowaiver area should be to stimulate the
various regulatory authorities to change and improve their regulations, so that they
all apply “best science” practice to BCS biowaiving. This would eventually lead to a
harmonization of biowaiver approaches throughout the world. It is to be hoped that
all major jurisdictions, including Japan, will one day be able to agree on prerequisites
and conditions for biowaiving, so that applicants and patients alike can benefit from
this innovative concept on a global basis. Although currently there is still a diversity of
opinion on the best scientific way forward, it is certain that through continued dialogue
through the publication of Biowaiver Monographs and discussions in science and
practice related conferences, this goal is achievable.
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