What Are the Steps of Drug Development?
We all see the commercials with happy people and happy music advertising a new or established medication. What are the steps leading up to this?
First, we’ve got preclinical trials. These are studies done in petri dishes (in vitro) and on mice (in vivo). This tests basic toxicity (potential to do harm) and efficacy of a candidate drug.
Next are clinical trials, starting with phase 1. In phase 1, safe dosage and potential human toxicity are tested on anywhere from 20 to 100 people (either healthy or with the condition). This takes a few months.
In phase 2, effectiveness and possible side effects are tested on hundreds of people with the target condition, taking up to 2 years.
Phase 3, taking several years, tests the same stuff as phase 2 but on up to 3,000 patients.
Of course, all participants are willing volunteers.
After these three phases, the drug is reviewed by the FDA for potential approval. If the drug is approved, phase 4 essentially monitors the long term side effects of the on-the-market drug to check two main factors: if it continues to be effective in the long run and if there are any long-term side effects that could result in withdrawal from the market.
The next time you get a headache, think of the thousands of patients and millions of dollars that went into developing your pill!
Fun Fact: The average preclinical study for candidate drugs costs $1.2 million USD!
Main Source: www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
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