March 21, 2019

There are drug adverse events, and then there are the Voldemortsof drug adverse effects, whose which-must-not-be-named.  Bleeding in your stomach lining is one. Basically, you can lose half of your blood volume before the blood appears at the “exit point” alerting you...

March 21, 2019

This one comes out of the past, but it is about a fear as old as time . . . or at least as old as Merck, namely that testing in animals does little to predict efficacy or safety in humans.  Actually, check that. It is actually the rule rather than the exception: Testin...

November 20, 2018

While most adverse phenotypes emerging in vivo late in drug development are unpredictable, progress has slowly but surely been made in avoiding drug attrition due to a few common adverse phenotypes. The most well-known of these is hERG channel effect resulting in long...

October 18, 2018

Clinical holds are lost battles in the war against drug attrition.  The process of drug development critically revolves around the FDA’s Investigational New Drug (IND) application, which is the document required to start testing the drug in humans.  Any safety, efficac...

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