absorption, distribution, metabolism and excretion,
all of which affect the activity of a compound in
vivo"
(Exh. 2002 at ¶15); and
(2) "...in vitro activity alone is not a reliable
predictor of in vivo activity" (Exh. 2002 at ¶26).
(b) the testimony of Dr. Denis Riendeau that:
(1) "In vitro inhibition of COX-2 is necessary,
but considered alone, is not sufficient to make
reliable predictions concerning in vivo
effectiveness of compounds and takes no account of
absorption, distribution metabolism and excretion,
all of which affect the activity of a compound in
vivo" (Exh. 2003 at ¶17); and
(2) "I also believe that activity in an in
vitro assay is not sufficient to make reliable
predictions concerning in vitro effectiveness of
compounds and takes no account of absorption,
distribution, metabolism and excretion, all of which
affect the activity of a compound in vivo" (Exh.
2003 at ¶27).
24. The Prasit application contains no in vivo data
demonstrating the efficacy of the compounds Prasit claims.
11
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