Dear Colleagues,Back to the Top
A warm hello from the Philippines!
In the Biointernational Conference held in London last October 8-10,
2003 of which I was privileged to attend, it was mentioned that FDA is no
longer recommending individual bioequivalence (IBE) due to several
reasons i.e. IBE requires repeat administration of both test and reference
products (ethical reasons) , strong resistance from the industry, trade-off
between mean difference and difference in variability and many considered IBE
as an statistical artifact and not an attribute of product quality. It was
also mentioned that replicated cross-over studies are not necessary for
average bioequivalence of highly variable drug products but is critical when
individual BE approach is used.
Here in the Philippines and in the ASEAN region, the approach is the
average bioequivalence analysis. I have been browsing the internet and
FDA website for a publication or documentation regarding FDA's final
stand on IBE but I could not find one. Also, please enlighten me on when to
use replicated cross-over studies - is this necessary for average
bioequivalence analysis? Further, what would be the best option to
consider for variable drug products in case the 90% confidence interval
falls slightly above the BE acceptance limit of 80-125%?
Thank you so much for all the support you are extending to us. Your
technical advices greatly help us in our BA/BE undertaking.
Jocelyn L. Jacob
Clinical Investigation Department
Medical Affairs Division
United Laboratories, Inc.
Tel. 632-631-8501 local 7086
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