Tag Archive: analytical testing

Mar 10 2011

Therapeutics for Rare and Neglected Diseases – How Rare is Rare?

The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States.  As insignificant as this classification may sound, collectively there are more than 25 million people in the United States affected by approximately 6,800 rare diseases. These rare diseases are alarmingly overlooked and under researched. …

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Jun 23 2010

Adaptive Designs and Clinical Supplies

In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.  My perspective concerns challenges related to clinical supplies (CS) presented by adaptive trial designs. FDA defines an adaptive design clinical study as “a study …

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