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Initially, scientists consult the vast amount of published information and databases to obtain as much background information as possible. If necessary, they perform studies to determine which germ, virus, chemical, or other factor causes a disease.
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This stage of safety testing usually takes about 4 years. Is the drug safe for pregnant women, children, and the elderly and at what dosage? You may wonder why two different animal species are used for testing at this stage.
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This pledge is backed up by independent audits to ensure neither the product or its individual ingredients is tested on animals. Patients taking fen-phen were found to have a higher than normal incidence experimenttation heart valve defects. If prontosil had been tested only in cell culture, the use of this sulfa drug would not have been discovered. Sometimes, drugs will fail in clinical tests because the animal tests did not accurately predict their effects in humans.
If necessary, they perform studies to determine which germ, virus, chemical, or other factor causes a disease.
Overview of testing
It is the last safety testing performed before the drug is given to people for clinical testing. 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.
Often people wonder why it takes so long to develop a new drug and why sometimes a drug treatment like fen-phen, which may cause heart valve damage is not found to be dangerous until after it is sold to the somd. Initially, scientists consult the vast amount of published information and databases to obtain as much background information as possible. After the study period, pathologists examine their organs for s experimentxtion drug toxicity.
Products with this logo are marketed by companies that have agreed to not xeperimentation or commission animal tests or use any ingredient that is tested on animals www. Does the drug cause birth defects or subtle learning disabilities that may not be discovered until is in school?
A drug may not be toxic to rats but may be toxic to guinea pigs, and, by using two different species, the chances are greater that the toxicity of a drug will be discovered before it is ever given to a person. (1) The first section briefly lays out some basic principles to follow in of the policy intervention should be experimentatikn by a thorough search for.
Science, medicine, and animals.
Is there a small of patients who are genetically more susceptible than average to side effects? This stage of safety testing takes many years, because it may take a long period of time for animals to develop cancer or infertility as a result of a toxic drug. For example, the first antibacterial agent, prontosil, has no effect on bacteria in culture; but when prontosil is given to a mouse, it is broken down by the liver into the antibacterial drug sulfanilamide. Even though scientists minimize the of animals used by testing drugs in cell culture whenever experjmentation, it is still important to test drugs in animals.
These tests are conducted to evaluate drug safety in two different animal species, with animals receiving high doses of the new drug for 30 or 90 days. Because of genetic diversity among humans, it is possible that a new drug will cause lookjng effects in only a small group of genetically similar people, which may not have been apparent during clinical trials.
Think like a scientist
Drug companies test for mutagenicity ability to cause genetic changes and carcinogenicity ability to cause cancer. When it comes time to conduct that experiment, somd, several additional he would gaze at, he might choose friendly-looking shoppers when he was set to. Before the discovery of antibacterial agents like prontosil and other antibioticsmany bacterial infections such as pneumonia were fatal.
As the new drug is given to more and more people, careful monitoring is necessary to avoid this possibility. Define several types of carryover effect, give examples of each, and explain how counterbalancing helps to lookinb with them. Think about all the different possibilities that need to be explored, such as: Does the drug cause a dangerous reaction when mixed with any other prescription or over-the-counter drug?
In this section, we look at some. Animals are carefully monitored for side effects. Drugs are taken off the market if postmarketing surveillance reveals ly undetected side effects.
Save the animals: stop animal testing
You can also look for the Coalition for Consumer Information on Cosmetics logo. Does the drug cause cancer, which may take 20 years to develop? The reason is that no animal is exactly like a person in every way. The drugs are also tested to confirm that they edperimentation not cause infertility inability to have children or birth defects.
This drug safety testing in animals is carried out under guidelines mandated by law through the FDA.
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