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Human Drug Testing

Human Drug Testing. Compiled by Katherine Papacostas, content obtained from the U.S. Food and Drug Administration (FDA). How does a drug get from a lab to your medicine cabinet?. Long unique route for every drug, but there are 2 main steps Pre-clinical research

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Human Drug Testing

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  1. Human Drug Testing Compiled by Katherine Papacostas, content obtained from the U.S. Food and Drug Administration (FDA)

  2. How does a drug get from a lab to your medicine cabinet? • Long unique route for every drug, but there are 2 main steps • Pre-clinical research • In microorganisms and/or animals • Clinical trials • In humans • Important uses of drugs are often discovered by accident! • Example: Retrovir

  3. Stages of Drug Development and Review Step 1: Pre-clinical research • Done in research institutions (universities, medical schools, pharmaceutical companies, etc.) • Done when a chemical is synthesized/discovered that is thought to act against a particular biological target that might be important in disease… • BUT nothing is known about how safe it may be to humans • AND it is not known if it is going to actually work in the first place

  4. Stages of Drug Development and Review Step 1: Pre-clinical research • To be able to test on humans, researchers must: • Show their results to the FDA, (including what animals they used, how effective their drug was on treating the disease, and what they propose to do for human testing) • Then the FDA decides whether they want to approve this…or send the researchers back to lab

  5. Stages of Drug Development and Review Step 2: Clinical trials • Clinical trials are typically divided into 3 “Phases” depending on # of subjects involved and the goal of the phase • Phase 1 studies: involve 20-80 people • Phase 2 studies: involve up to 300 people • Phase 3 studies: involve 300-3,000 people

  6. Stages of Drug Development and Review Step 2: Clinical trials  Phase 1 • Conducted in healthy volunteers between the ages of 20 and 80 • Why not just use sick people? • Phase 1 is about: • determining how harmful any side effects are • How long the drug stays in the body • Would YOU volunteer? • These people are often paid well (sometimes thousands of dollars)

  7. Stages of Drug Development and Review Step 2: Clinical trials  Phase 2 • Only reached if Phase 1 studies don’t reveal unacceptable toxicity • Phase 2 is about: • Effectiveness of the drug…so what type of people do you think they use? • Sick! So get volunteers that have a certain condition that the drug is supposed to treat • Would YOU volunteer now? • (if you were sick with some disease that this drug might treat)?

  8. Stages of Drug Development and Review Step 2: Clinical trials  Phase 3 • Begin if effectiveness is shown in Phase 2 • Studies gather more information about: • Safety and effectiveness • How might you go about doing this? • Usually study different populations of people • Experiment with different dosages • See how the drug impacts a person when taken with other drugs

  9. Stages of Drug Development and Review • Once through Phase 3  Drug submitted to FDA once more with ALL results (pre-clinical research, all phases of clinical trials) and hope for approval • If FDA decides benefit of the drug outweigh the risk it is approved to be marketed in the US • Sometimes still denied • How long do you think this process takes? • Why does it take so long?

  10. Bumps in the Road • Why the delay or denial of a drug that proves effective in all phases of clinical trials? • If clinical trials unearth some unexpected safety risk • Manufacturing issues • When trying to mass produce a drug, sometimes have quality control issues • Don’t want to distribute contaminated drugs (GlaxoSmithKline lawsuit January 2011) • Don’t want to create the wrong drugs by mistake!

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