Back to the Top
Dear All,
We have used a replicate crossover (4 period, 2 sequence) design for
testing bioequivalence of one of our formulation. Two sequences used
in the design were RTRT and TRTR. Now my question is as intra CV for
reference is well above .70 or 70% can we go for reference scaling
average bioequivalence approach (RSABE) if we are targeting US market?
One more question is that can we apply RSABE if this approach is not
specified in the protocol and if yes is it acceptable to U.S. FDA.
Waiting for your invaluable comments and suggestions.
Thanks & Regards,
Ravi Shankar Pandey
Back to the Top
The following message was posted to: PharmPK
If you haven't finished the protocol you can amend it. If you have
finished
the protocol, the changes are a deviation and you must issue a
deviation,
describing the changes and impact to the original study. Since the
original
study was approved by an IRB, you have got to address the changes with
them
as well. Otherwise you are putting the IRB in a bad position.
Back to the Top
The following message was posted to: PharmPK
Could you please focus on RSABE (reference scaling average
bioequivalence)? Thanks in advance/Mitesh
Back to the Top
Hi Ravi Shankar,
RSABE approach has been recommended by FDA for lansoprozole and
lovastatin.
http://www.fda.gov/cder/guidance/bioequivalence/recommendations/Lansoprazole_DRODT_21428_RC10-08.pdf
http://www.fda.gov/cder/guidance/bioequivalence/recommendations/Lovastatin;_Niacin_ERtab_21249_RC12-08.pdf
Additional resources-
Following article by Haidar et al from folks at FDA might be helpful.
Bioequivalence Approaches for Highly Variable Drugs and Drug Products.
Pharmaceutical Research, Vol. 25, No. 1, January 2008 (# 2007)
http://www.springerlink.com/content/u503p62056413677/fulltext.pdf
http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_4_files/frame.htm
Best
Ganesh Mugundu
--
Ganesh M Mugundu
PhD Candidate
Departmentof Pharmacokinetics & Biopharmaceutics,
College of Pharmacy
University of Cincinnati
Blog: http://pk-pd.blogspot.com/
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Reference Scaling Average Bioequivalence Approach (RSABE)" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)