NR565 Week 1 Study Outline

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NR565 Week 1 Study Outline Many questions are written to assess your clinical application of the material from the textbook, in real-world scenarios. Chapter 2: Review of Basic Principles of Pha... rmacology How new drugs are developed : the early part of the drug development process is called the preclinical stage. Identification of promising drugs and their testing in animals occur during this stage. Pharmaceutical companies will identify a drug target, starting sometimes with ingredients isolated from a plant (or organism in the case of antibiotics) with desirable medicinal properties, sometimes with a molecular target identified in the body to produce the desired response, and sometimes with a disease in need of treatment. Preclinical studies are performed on cells, isolated tissues and organs, and in laboratory animals to identify promising compounds. During the clinical stage of new drug development, pharmaceutical companies must establish the safety and effectiveness of new products in humans. Phase I clinical trials typically establish biological effects as well as safe dosages and pharmacokinetics in a small number of healthy patients. During phase II clinical trials, new drugs are used to treat disease in a small number of patients and to establish the potential of the drug to improve patient outcomes. If the drug still looks promising, phase III clinical trials will compare the new medication to standard therapy in a larger number of patients studied by at sites across the country. New drugs must be at least as good as, and it is hoped better than, other available therapies. Throughout the process, pharmaceutical companies work with the FDA. During clinical trials, only several thousand patients receive a new drug. During the post-marketing period, a larger population of patients receives the drug, and sometimes much is learned about additional adverse effects that occur infrequently with use of the drug. Drug responses : There are two basic types of drug responses: quantal and graded. These responses differ in how they are measured and dictate dosing decisions to achieve the desired effect. [Show More]

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