http://pharmaweblog.com/blog/2007/05/21/revisiting-premarketing-risk-evaluations/ Pharmaceutical and biotech science and business Wed, 20 Aug 2008 10:47:02 +0000 http://wordpress.org/?v=2.0.2 http://pharmaweblog.com/blog/2007/05/21/revisiting-premarketing-risk-evaluations/#comment-59 Tue, 29 May 2007 20:54:50 +0000 http://pharmaweblog.com/blog/2007/05/21/revisiting-premarketing-risk-evaluations/#comment-59 [...] “Have a look at my prior post on premarketing risk evaluation.  When you consider what’s happening aound Avandia (e.g. Therapeutics Daily), it puts my argument into sharp focus.  Better definitions of risk from premarketing evaluations are needed for drugs like Avandia; I see no way around it.  If sponsors don’t have the sense to do the necessary studies, I suppose it’ll be forced on the industry.  A shame that. Share with the world: These icons link to social bookmarking sites where readers can share and discover new web pages. [...] […] “Have a look at my prior post on premarketing risk evaluation.  When you consider what’s happening aound Avandia (e.g. Therapeutics Daily), it puts my argument into sharp focus.  Better definitions of risk from premarketing evaluations are needed for drugs like Avandia; I see no way around it.  If sponsors don’t have the sense to do the necessary studies, I suppose it’ll be forced on the industry.  A shame that. Share with the world: These icons link to social bookmarking sites where readers can share and discover new web pages. […]

]]> http://pharmaweblog.com/blog/2007/05/21/revisiting-premarketing-risk-evaluations/#comment-58 Mon, 21 May 2007 23:52:16 +0000 http://pharmaweblog.com/blog/2007/05/21/revisiting-premarketing-risk-evaluations/#comment-58 Postscript: At the time I wrote this piece this morning, I hadn't realized that a meta analysis implicating GSK's Avandia in excess risk of cardiovascular disease and death had been published online in the NEJM today. If substantiated, this finding supports my contention that judicious use of large, simple safety studies for chronic use-drugs that target large populations is warranted during phase 3 clinical testing. Postscript: At the time I wrote this piece this morning, I hadn’t realized that a meta analysis implicating GSK’s Avandia in excess risk of cardiovascular disease and death had been published online in the NEJM today. If substantiated, this finding supports my contention that judicious use of large, simple safety studies for chronic use-drugs that target large populations is warranted during phase 3 clinical testing.

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