![]() ![]() ![]() The picture is even worse for cardiovascular (CV) agents 6.6% of CV drugs entering phase I advance to market, 24% that enter phase II transition to phase III, and 45% that enter phase III result in a new drug application filing (4). Following phases II and III, 30.7% and 58.1% of drugs fail, respectively (4). The timeframe for passage of a therapeutic agent through clinical testing for Food and Drug Administration (FDA) marketing approval is approximately 12 years (2), with costs now estimated from $1 billion to $1.8 billion dollars 2, 3.Ī recent study by the Biotechnology Innovation Organization of clinical success rates in advancing drugs to market between 20 found that only 9.6% of drugs entering phase I clinical testing will reach the market (4). Human clinical trials for drug development traditionally progress from small toxicity trials in healthy volunteers (phase I) to proof-of-concept and dose-finding trials in somewhat larger groups of patients with the target condition (phase II) (1), and finally to randomized trials to further delineate clinical efficacy, outcomes, and adverse events in large groups of patients (phase III). ![]()
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