Back to the Top
Dear Group
I would like to explore you opinions on the following issue: A drug
product in an enteric coated multi-particulate dosage form (generic
product) to be compared in a bioequivalence study with a brand
product which is also enteric coated multi-particulates dosage
form. Dissolution in phosphate buffer of pH 6.8, 15 min, the
generic product releases about 10 to 20% less than the brand
product. At 30 min and later time points, both are about the same.
How relevant the 15 min point to the bioequivalence taking into
considerations the gastric residence time of the pellets under fasted
and fed conditions and the small intestinal transit time of the pellets.
Your expert input in this issue is greatly appreciated.
Thanks
Nabil
Back to the Top
The following message was posted to: PharmPK
Hi, in my opinion you are not evaluating a Bio- Equivalence parameter
but only a dissolution porfile.
The two aspects are completely (even if related) DIFFERENT.
Bio equivalence must be tested in healthy volunteers, dissolution
profile can helps you in order to evaluate the formulation before the
trial.
Best regards
Fabio
Back to the Top
The following message was posted to: PharmPK
HI Fabio
I have not seen the previous message that led to you
answer but you are missing some important points.
both FDA and EMEA BA/BE guidelines accept similar
methods for assessing bioequivalence. The list
includes not only clasical PK studies in human healthy
volunteers BUT also in vitro methods if they are
justified and validated.
Bioequivalence is an essential quality standard that
any drug product must demonstrate. The point is to
choose the most adequate method for assessing BE. and
not ALWAYS the most adequate method is an in vivo
study.
so I would not say BE "must be tested in in healthy
volunteers".
marival
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)