Anonymous
Anonymous asked in Science & MathematicsMedicine · 1 decade ago

please help! chemistry FDA question!!!!?

how does the FDA test drugs for safety without human testing! i need this immediately, please give a good well written answer if you want best answer. i cant find this info anywhere else.

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  • Az R
    Lv 6
    1 decade ago
    Best Answer

    The FDA doesn't do the testing, it demands testing establishing a certain level of safety before they'll allow human drug trials to take place. The company that's making the drug has to prove they did this.

    It's called pre-clinical testing. It usually involves cells at the first stage - you grow human cells and test for certain things(like HEA-G interactions), or do an Ames test to see it causes cancer. Then you test it in animals if it can be done, usually mice, though sometimes they use other animals like rabbits - it really depends on what they need done. For almost everything, mice are good enough - this gives them pharmacokinetic and pharmacodynamic data, it also establishes if there's any sort of toxicity, like to muscles or kidneys and the like.

    All of these have to come out looking pretty much perfect for a drug to get tested in humans. Which is when we have Phase I-III testing.

  • 1 decade ago

    The FDA uses animals (rats, mice, they have a similar DNA structure to humans) for preliminary testing before they make it to Phase I-III trials. A drug cannot make it to the market though unless it has been put through Phase I,II, and III clinical trials.

    http://www.essortment.com/all/fdadrugapprova_rrgy....

    http://www.fda.gov/cder/regulatory/applications/

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