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. 11Page: Previous 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 NextLast modified: November 3, 2007