Clinical trial

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  • Clinical Trial Process

    1. Describe the clinical trials process of how a drug is approved by the FDA. The clinical trials process can be divided into four phases. Phase one, the researchers recruit a small group of healthy people (20-100 people) into the trial. This phase focuses on absorption, distribution, metabolism and elimination. The small dose will be administered. At the end of phase one, the safe dosage and the best route to administer drug will be set. Phase two is similar to phase one. The difference is that in this phase, the researchers recruit a small group of people who has suffered from the disease which the drug is supposed to effect on. At the end of phase two, the effective dosage and its interval will be determined. In phase three, the researchers…

    Words: 702 - Pages: 3
  • Adaptive Design In Clinical Trial

    towards adaptive design in a clinical trial as per the U.S.FDA guidance. The adaptive trial design gives greater benefit compare to the traditional drug trial design for the success of the new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in the clinical trials. Adaptive trial design allows researchers modification in the clinical trial and statistical procedure of the clinical trial…

    Words: 1414 - Pages: 6
  • Clinical Trials And Obligations

    Clinical trials ought to be conducted under calibrated statutory regimes where: 1) There is full disclosure to the patient undergoing the trial. 2) The right to withdraw at any stage without any consequence. 3) Comprehensive medical insurance. 4) Meticulous monitoring after administration of the drug for serious adverse effects. 5) Free access to the drug for the trial participants when it is cleared for commercial use. The bodies responsible for regulation of Clinical Trials are as follows:…

    Words: 979 - Pages: 4
  • Case Study Of Husky Pharmaceuticals

    and senior) in both Gender, Healthy Volunteers accepted. The following Informed Consent has two parts: 1) Information Sheet (detail of research) 2) Certificate of Consent Part one: Information Sheet Please read this form carefully. It gives you the vital data and objectives about the clinical study. An individual from our investigation group will communicate with you about participating in this investigational study. Individuals…

    Words: 1622 - Pages: 7
  • Why Are Primary Endpoints Important

    Primary endpoints are the most important aspect of the clinical trials that help determine their relevance in regards to research and development. It is the outcome by which the effectiveness of treatments in a clinical trial is evaluated. Because of its importance, it is essential for primary endpoints to be concisely and carefully specified to ensure that the results will be accurate and accepted in the scientific community. They must possess important characteristics that ensure qualitative…

    Words: 998 - Pages: 4
  • Business Ethics Case Study: CV Therapeutics

    pharmaceutical companies have been scrutinized heavily for several years. There appears that pharmaceutical companies are emphasizing more on the drugs fitting scare mongering, as well as problems that are over medicalized. Thorough testing and clinical trials are essential to have medical drugs that are good, but it seems there are several shortcuts that comprise of pressuring to have results which are favorable, carrying tests on people minus their consent, as well as applying drugs for uses…

    Words: 1740 - Pages: 7
  • Biosimilar Case Study

    Phase III Multinational Clinical Trials for Biosimilar USFDA and Health Canada have established exclusive approval pathways for biosimilars, they are not identical copies of their originators but needs to show a highly similar structure and similar clinical efficacy, safety and immunogenicity to their approved reference biologics. The main goal is to approve biosimilars are to reduce the cost and make it available to the large population. Biosimilars also undergo for testing at all stages of…

    Words: 1117 - Pages: 5
  • Fdma Phase 4

    commitment (Phase IV Trial). I am going to discuss this matter with my boss. It is a signed commitments with FDA given by a sponsor before or after product approved by FDA to gather additional information about a product 's safety, efficacy, or optimal use. The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Food, Drug and Cosmetic Act signed into law on November 21, 1997 by adding a new section 506B (21 U.S.C. 356b). FDA issued a draft guidance related to this rule…

    Words: 895 - Pages: 4
  • Oral Anticoagulation Analysis

    thromboembolism, encompassing deep vein thrombosis and pulmonary embolism, has been increased in cancer patients, adversely affecting their prognosis. Low-molecular-weight heparins are recommended as efficacious and safe anticoagulation treatment in cancer patients. However, in clinical practice, oncologists prefer oral anticoagulation, especially if long-term or extended treatment is necessary. The novel oral anticoagulants have recently emerged as an alternative to the standard therapy owing…

    Words: 982 - Pages: 4
  • Jessie Gelsinger Case Summary

    adverse reactions to patients already in the clinical trial to Jesse or the FDA (R. Wilson, 2010). It also did not advise the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) about changes to study design, like the change in route of administration of the adenovirus (R. Wilson, 2010). In addition, it was not safe because the selection of trial subjects was not ethical as the trial’s aim was to help infants with the disorder, yet it enrolled asymptomatic adult who had…

    Words: 1026 - Pages: 5
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