Clinical trial

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  • 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 after commencement of a clinical trial without harming trial’s validity and integrity. Traditional drug trials were conducted on a set of very strict rules without inflexibility. Gottlieb…

    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
  • 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
  • Case Study On Diabetes

    Rationale Diabetic patients have major risk of cardiovascular disease leading cause of morbidity and mortality. The aim of this study is the importance of choosing drugs that do not increase cardiovascular risk and reduce the risk of cardiovascular events. The US FDA and has recommended its Guidance for Industry for drug developers in 2008 that new drugs for type 2 diabetes undergo clinical trials should fulfill cardiovascular safety in addition to glycemic benefit and rule out potentially…

    Words: 918 - 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
  • RW Advantages And Disadvantages

    treatments Thinking Beyond the Clinical trials Though clinical trials are the gold standard measuring the safety and efficacy of drugs, to evaluate the cost-efficiency of a drug in a real-world environment and measure its impact on quality of healthcare, RCTs need to be supplemented or followed up with the comparatively new standard, called real-world evidence (RWE). Real world evidence has is entering every part of the drug product life cycle from discovery to the late stage marketing. RWE…

    Words: 1597 - Pages: 7
  • Essay On Henrietta Lacks Unethical Research

    woman of significant importance, and a woman of color was violated by health care professionals. Through the lens of “The Immortal Life of Henrietta Lacks” unethical scientific research is what could be derived from the violation of Henrietta and her cells for if proper scientific guidelines were in place the spread of the HeLa cells would have been minimized. Additionally, The WillowBrook Study case of 1956 involved the exploitation and abuse that health care providers imposed on young…

    Words: 1153 - 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
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