BIOLOGY 445 Lecture Notes - Lecture 3: New Drug Application, Investigational New Drug, Center For Drug Evaluation And Research
18 Sep 2017
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Pharmacology lecture 3a- drug development: describe the role of the food and drug administration in medication safety. As part of the food and drug administration, the center for drug evaluation and. Research (cder) helps to evaluate and regulate over-the-counter and prescription drugs before they can be sold. These can include biological therapeutics, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens: define pre-clinical research and clinical studies. Pre-clinical research is conducted before clinical trials on humans can occur; sponsors determine is the drug is reasonably safe for use in humans. After this testing researchers review their findings and decide whether the drug should be tested in people. This testing answers basic questions about a drugs safety. Clinical studies test whether new medical approaches, treatments, drugs, or devices are safe and effective for humans. These also show which medical approaches work best for certain illnesses or groups of individuals: describe phase 1, 2, 3 and 4 clinical trials.
