5 ms·
Imagine having to do 10 year studies on any drug before releasing it.
by jankyxenon 6y ago
Imagine having to do 10 year studies on any drug before releasing it.
- chrisco255 6y agoIsn't that the average for a new drug? "The full research, development and approval process can last from 12 to 15 years." "If the FDA gives the green light, the investigational drug will then enter three phases of clinical trials: Phase 1: About 20 to 80 healthy volunteers to establish a drug's safety and profile, and takes about 1 year. Safety, metabolism and excretion of the drug are also emphasized. Phase 2: Roughly 100 to 300 patient volunteers to assess the drug's effectiveness in those with a specific condition or disease. This phase runs about 2 years. Groups of similar patients may receive the actual drug compared to a placebo (inactive pill) or other active drug to determine if the drug has an effect. Safety and side effects are reviewed. Phase 3: Typically, several thousand patients are monitored in clinics and hospitals to carefully determine effectiveness and identify further side effects. Different types and age ranges of patients are evaluated. The manufacturer may look at different doses as well as the experimental drug in combination with other treatments. This phase runs about about 3 years on average." https://www.drugs.com/fda-approval-process.html https://www.drugs.com/fda-approval-process.html
- jankyxenon 6y agoYour longest phase there is 3 years. The length of observation of any individual in that phase will be less. If you had had observations of subjects lasting 10 years - your overall process would be much much longer than 10-12 years.