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Science, Medicine, and Animals (2004) / Chapter Skim
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Safety Testing
Pages 21-28

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From page 21...
... ........... CONSUMER PRODUCTS TESTING In 1933, more than a dozen women were blinded and one woman died from using a permanent mascara called Lash Lure.
From page 22...
... ALTERNATIVES TO ANIMAL TESTING Alternative testing methods are developed to replace, reduce, and refine animal use and to improve the accuracy of tests for predicting human health or environmental hazards. An example of an alter native testing method is an assay that uses in vitro cell cultures to determine whether chemicals will burn or damage the skin.
From page 23...
... The Lash Lure and Elixir Sulfanilamide tragedies led to the passage of the Food, Drug, and Cosmetic Act of 1938. This act provided government oversight of consumer product safety and enforceable food standards and mandated that a drug company must prove to the FDA that a drug is safe before it can be sold to the public.
From page 24...
... Then the mechanisms of the disease are studied and new drugs are developed and evaluated for effectiveness and side effects using cell culture and whole animal models. Even though scientists minimize the number of animals used by testing drugs in cell culture whenever possi ble, it is still important to test drugs in animals.
From page 25...
... CLINICAL TRIALS If no problems arise during preclinical testing, the drug company applies to the FDA for an Investigational New Drug Application, which authorizes the drug company to administer a new drug to people for clinical testing. PHASE I TRIALS -- A new drug is administered to a small number of normal, healthy human volunteers to study its activity and to monitor potential toxicity in people.
From page 26...
... ........... PHASE III TRIALS -- Large multicenter studies enroll thousands of patients to test the drug's effec tiveness and to continue to monitor for any side effects.
From page 27...
... Is the drug safe for pregnant women, children, and the elderly and at what dosage? Does the drug cause birth defects or subtle learning disabili ties that may not be discovered until a child is in school?
From page 28...
... Because the government has not legally defined "cruelty free," it can mean many different things. While most cosmetic companies that label their products "cruelty free" use alternative safety tests that do not use animals, "cruelty free" can also mean: - the final product was not tested on animals, but the ingredients were individually tested on animals.


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