what is the phase 1 clinical trial?
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Phase I. Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients.
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The goal of a preclinical drug discovery program is to deliver one or more clinical candidate molecules, each of which has sufficient evidence of biologic activity at a target relevant to a disease as well as sufficient safety and drug-like properties so that it can be entered into human testing.
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Chemotherapy is usually not part of the treatment regimen for earlier stages of cancer. Stage 1 is highly treatable, however, it does require immediate treatment, typically surgery and often radiation, or a combination of the two.
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Oncology is somewhat more complicated than other therapeutic areas. The endpoints, for one, differ greatly. For example, rather than running a clinical trial to test the safety and efficacy of an antibiotic against an infection, an oncology trial is trying to extend and improve a subject's quality of life.
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Cell cycle phase specific agents act on the cells in a specific phase. They are most effective against tumours that have a large proportion of cells actively moving through the cell cycle and cycling at a fast rate.
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A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
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Meiosis prophase 1. Prophase 1 of Meiosis is the first stage of meiosis and is defined by five different phases; Leptotene, Zygotene, Pachytene, Diplotene and Diakinesis (in that order).
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The purpose is for cells to grow, develop, and carry on their normal metabolic functions. What is the first phase of interphase?
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['Introduction. The introduction phase is the period where a new product is first introduced into the market. ... ', 'Growth. ... ', 'Maturity. ... ', 'Decline.']
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The exponential phase is the first phase of PCR amplification. Reaction components are in excess, there is an exact doubling of product each cycle, and the reaction is specific and precise. Real-Time PCR measures the Cq value at this phase of PCR. The linear phase is the second phase of PCR amplification.
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In Stage 1 breast cancer, cancer is evident, but it is contained to only the area where the first abnormal cells began to develop. The breast cancer has been detected in the early stages and can be very effectively treated. Stage 1 can be divided into Stage 1A and Stage 1B.
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['Phase 1: The PI system demo. In this phase, product management acts as the facilitator of the demonstration that covers the fully integrated system. ... ', 'Phase 2: Quantitative measurement. ... ', 'Phase 3: Retrospective and problem solving.']
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A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective.
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['Phase 1: Setting Objectives. The first and most important phase is setting objectives. ... ', 'Phase 2: Planning. ... ', 'Phase 3: Execution. ... ', 'Phase 4: Measurement. ... ', 'Phase 5: Control.']
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['Phase 1: Hemostasis Phase.', 'Phase 2: Defensive/Inflammatory Phase.', 'Phase 3: Proliferative Phase.', 'Phase 4: Maturation Phase.']
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Introduction. Clinical studies can be divided into two broad categories: trials, in which the investigator intervenes to prevent or treat a disease, and observational studies, in which the investigator makes no intervention and patients are allocated treatment based on clinical decisions.
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Phase I reactions of drug metabolism involve oxidation, reduction, or hydrolysis of the parent drug, resulting in its conversion to a more polar molecule. Phase II reactions involve conjugation by coupling the drug or its metabolites to another molecule, such as glucuronidation, acylation, sulfate, or glicine.