time, cost, and success rate of developing a new drug for treating a rheumatic disease
It takes 10 years and $1 to $2 billion from the time a new drug is tested in mice until it makes it to the market.
- • Preclinical phase (efficacy, toxicity, and pharmacokinetics in animals): only 2% of new drugs tested make it out of this phase.
- • Phase 0 and I trials (drug metabolism [Phase 0] tested in 10 normal volunteers and dose ranging and safety [Phase I] tested in 20 to 100 normal humans): 70% of drugs make it out of this phase.
- • Phase II trials (dose [Phase IIA] and efficacy/safety [Phase IIB] tested in 100–300 patients with disease): 33% of drugs make it out of this phase.
- • Phase III trials (efficacy and safety tested in 1000 to 2000 patients with disease): 80% of drugs make it out of this phase to market.
- • Overall, one out of five (20%) drugs entering Phase I make it to market.
