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Tag Archives: adaptive trials
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In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.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) … Continue reading
Posted in Clinical Trials
Tagged adaptive design, adaptive trials, analytical testing, API, clinical supplies, clinical trials, drug product, FDA, guidance, labeling, manufacturing
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Analysis of FDA Guidance on Adaptive Designs
In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s … Continue reading
