how does the fda approve drugs?
In: 2
Company makes a drug->test it on cells in a dish-> tests it on animals. All of that is preclinical.
Clinical testing starts after the preclinical part is approved:
Phase 1- testing the drugs in humans to see how safe it is and to find the best dose. This is in healthy people and sometimes people in the later stages of diseases. Whether the drug actually works or not will be addressed in later phases
Phase 2- testing if the drug works in humans, plus checking side effects and safety.
Phase 3- testing if the drug works in humans, but in a larger sample. If a drug finishes phase 3, it can get officially approved for sale/use. Keep in mind this whole process from preclinical to completion of clinical (usually) takes many years
Phase 4- this is after the drug is approved and on the market. This is just looking for adverse events and checking that all is going well.
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