A New Drug Development Process

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Introduction: A new drug development process starts with animal testing, before it is been tested in humans. These animal studies are designed to ensure that the drug is effective and safe in animals. Moreover, the results obtained should be reproducible. But even the reproducible results on animal studies cannot provide relevant prediction of the safe and effectiveness of a new drug. Scientists often stipulate the structural and physiological similarities between human and animals as a reason for performing animal testing and then relating or extrapolating the results for the first in human clinical testing, also known as Phase I clinical trials. Although, it is very clear that the human life expectancy is much higher compared to animals, because of the way things metabolize in human body, or to the environment a human body is exposed to or due to the minute genetic difference between human species and some other species. Also, diseases which are imposed by genetic engineering into the animals during animal studies differ significantly than the natural occurrence of a disease. Scientists are aware of these flaws that come with the use of animal model testing, like drugs that may be safe and effective in animals might not necessarily be safe and effective in humans. One such example is “Thalidomide”, which was used in 1950’s as a sedative product and was used to treat morning sickness of pregnant women. This drug was totally safe and effective in animals, but when used
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