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| Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s), with the object of ascertaining its safety and/or efficacy. The terms "clinical trial" and "clinical study" are synonymous. (ICH) Before a medication can be sold over the counter or with a prescription, it must undergo rigorous testing. The process by which new medications are tested so they can ultimately be marketed to treat various diseases is as follows: |
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1. Development of a Compound Chemists in a laboratory develop compounds with a certain chemical structure that the scientists believe may function in humans to alleviate certain symptoms in a disease, or perhaps even cure it. |
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2. Pre-clinical Testing To prove that the compound works as is hypothesized and does not produce any negative side effects, it is first thoroughly tested in animals (i.e., mice, rats, dogs and monkeys). This stage of testing is commonly referred to as the "pre-clinical" stage. The purpose of these animal studies is to prove that the drug is not carcinogenic (cancer causing), mutagenic (causes mutations), or tetarogenic, and to understand how the drug is absorbed and excreted. Once a pharmaceutical company proves that the compound appears to be safe, and possibly effective in animals, the company will provide this information to the Food and Drug Administration (FDA) requesting approval to begin testing the compound (experimental drug) in humans via an Investigational New Drug (IND) application. |
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3. Clinical Trials/Studies in Humans The clinical testing of experimental drugs in humans is normally done in three phases (Phase I, II and III) with more and more people included in each subsequent phase. Before moving to the next phase of development the data is carefully analyzed to ensure the experimental drug is at least safe and well tolerated. After successful completion of Phase I-III testing, a company will submit the results of all of the studies to the FDA to obtain a New Drug Approval (NDA). Once the FDA grants a company with a NDA, the company can market the drug (medication) to the public. Additional testing (post-marketing or late phase III/phase IV) to look at the safety of long-term safety continues. |
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Phase I studies are primarily concerned with the drug's safety, and are the first time the drug is tested in humans. These studies are typically done in a small number of healthy volunteers (20-100), usually in a hospital setting where they can be closely watched and treated should there be any side effects. These volunteers are usually paid for their participation and for the most part tend to be men (approximately 30 years of age on average). The purpose of these studies is to determine how the experimental drug works in humans. That is, how is the drug absorbed, metabolized, and excreted. Additionally, they seek to determine what types of side effects occur as the dosage levels (that is, the amount of drug) are increased. The PSG is not involved in doing Phase I testing. However, it is during Phase I testing that the PSG is collaborating with the pharmaceutical company to plan Phase II and II clinical trials in PD. |
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Once an experimental drug has been proven to be safe in healthy volunteers, it must be tested in the patients that have the disease that the experimental drug is expected to improve/cure. |
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