About 90% of new drug candidates that enter clinical trials fail before reaching regulatory approval. Between 40% and 50% fail because they do not work well enough in humans, while about 30% produce unmanageable toxicity or side effects. Poor absorption and elimination account for another 10% to 15%, while commercial or strategic problems cause roughly 10% of failures. Developing one successful drug can therefore take 10 to 15 years and cost around $1 billion.
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