Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 180 for “"Food and Drug Administration"”.
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An Economic and Regulatory Analysis of Breast Cancer Drugs Approved by the US Food and Drug Administration
… cancer is the most common cancer among women and the leading cause of cancer death among women worldwide. The pharmacological options for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy, which are used for the prevention or treatment of breast cancer. …
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Approval of new drugs by the U. S. Food and Drug Administration: Problems with the process and access to unapproved drugs
<p>Today, the vast majority of drugs available for patient use have gone through a rigorous system of human clinical trials supervised by the Food and Drug Administration (FDA), to ensure the drugs are safe and efficacious. There are now citizen advocacy groups that seek use of drugs not yet …
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An Economic and Regulatory Analysis of Gene Therapy Products Authorized by the US Food and Drug Administration and the European Medicines Agency
… emerged as an alternative for preventing and treating disease. Concerns have been expressed about the clinical value and the high cost of gene therapies.</p> <p>Objective: This study assessed the authorization process of gene therapy products by the Food and Drug Administration (FDA) and …
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The vaccine and the virus: An autoethnographic account of HPV, sex education, and the psychosocial effects of STI's
<p>In 2006 the Food and Drug Administration (FDA) approved the Gardasil vaccine to assist in the protection from the Human Papillomavirus (HPV): The leading contributor to cervical cancer. After stressing the importance of the vaccine, but disregarding its inadequacies, young women were subjected …
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Spinal cord implants for nerve regeneration
… was developed to help aid in repair, recovery, and regeneration in the spinal cord following spinal cord injury (SCI). This is a polymer-based model with the ability to host neural stem cells. This document briefly reviews the SCI model developed. It also discusses the intellectual property …
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ETHICAL CONSIDERATIONS OF THE USE OF INVESTIGATIONAL NEW DRUGS DURING THE GULF WAR
… of the Gulf War in 1992, the threat of chemical and biological weapons prompted the Department of Defense to seek a waiver from the Food and Drug Administration to use the investigational new drugs pyridostigmine bromide and botulism vaccine without first obtaining consent from those servicemen …
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The trouble with white pants: medicalisation and agency in the context of menstrual suppression
… debates surrounding the United States of America Food and Drug Administration approval of the first ECOC called Seasonale in 2003. Rather than framing ECOC as simply a forward trajectory of biomedical technologies, or as a medical 'take-over' of another aspect of women's bodies, it examines the …
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MANUFACTURE OF INDIVIDUALIZED DOSING: DEVELOPMENT AND CONTROL OF A DROPWISE ADDITIVE MANUFACTURING PROCESS FOR MELT BASED PHARMACEUTICAL PRODUCTS
The improvements in healthcare systems and the advent of precision medicine initiative have created the need to develop more innovative manufacturing methods for the delivery of individualized dosing and personalized treatments. In recent years, the US Food and Drug Administration (FDA) introduced …
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Optimization of Signal-Detection Methods in Novel Databases: a Focus on Direct-Acting Antivirals
An adverse drug event (ADE) is an injury resulting from medical intervention related to a drug, and they include medication errors, adverse drug reactions, allergic reactions, and overdoses. In 2019, the Food and Drug Administration (FDA) identified the following outcomes as potential signals of …
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Review of drug and biologics recalls: 2009 through 2019
<p>This study analyzed drugs and biologics recalls for the period of 2009 and 2019. The data used in the study was generated from Food and Drug Administration records. A total of 466 drugs and 84 biologics were recalled during the 11-year period. The common causes of drug product recalls included …
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Influence of clinical research investigator fraud on clinical trial participation
… of clinical research investigators whom the Food and Drug Administration (FDA) has disqualified or totally restricted has been increasing since 1964. In addition, several public polls and surveys indicate a major dilemma in clinical trial participation and public perceptions of clinical …
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Pulmonary Valve Replacement
… It is currently under clinical trial to get food and drug administration (FDA) approval.</p> <p>This study is a comparison of the performance of Sapien 3 with surgical bioprosthetics. The in vitro tests result showed Sapien 3 experiences less degree of opening and effective orifice area in …
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Can Medicare afford to pay for oral chemotherapy drugs? : an evaluation of the problem and introduction of a model to estimate cost
Recently, effective oral cancer drugs are gaining prominence. This trend toward oral chemotherapy has important economic implications: the Medicare system of the United States pays for all intravenous (IV) chemotherapy, but it covers only those oral drugs that have an equivalent IV formulation …
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Changes in the characteristics of approved New Drug Applications for antihypertensives
… trial design has evolved for antihypertensive drug submissions reviewed and approved by the Food and Drug Administration between 1988 and 2001. To do this, I have constructed and undertaken a preliminary analysis of a number of quantitative surrogate measures of complexity and scale, such as …
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Business process analysis of yield data flow at a newly merged pharmaceutical company
Tracking, monitoring, and documentation of the manufacturing performance are significant for pharmaceutical companies under the regulations of Food and Drug Administration (FDA). However, the current yield data are not consistent and the business procedures for yield data flow are not unified and …
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AN AGENCY’S PATH TO INDEPENDENCE: HOW TO GAIN ADMINISTRATIVE AUTONOMY AS A U.S. GOVERNMENT AGENCY
… reviews the history of U.S. government agencies and analyzes the viability of their seeking wholesale autonomy. It also examines the impact of formal agency structure on agency autonomy for the Federal Trade Commission (FTC)—an independent agency—and the Environmental Protection Agency (EPA) and …
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The complex behavior of poly(dte) carbonate and its blend properties
… lactic acids (PLA), poly glycolic acids (PGA), and their copolymers have been studied intensely for bone regeneration purposes. Poly(DTE)carbonate has been found useful for bone regenerative purposes and is under review by the U.S. Food and Drug Administration. The purpose of this study was to …
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Exploring machine learning techniques using patient interactions in online health forums to classify drug safety
… collected from online message forums to predict drug safety using natural language processing and machine learning techniques. Drug safety is defined as any drug with an active safety alert from the US Food and Drug Administration (FDA). It is believed that this is the first exploration of …
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Design, synthesis and evaluation of small molecules as inhibitors of plasminogen activator inhibitor-1
… urokinase-type plasminogen activator (uPA) and tissue-type plasminogen activator (tPA), which regulates fibrinolysis as well as the development of different pathological diseases like obesity, metabolic syndrome, tumor invasion and metastasis, and coronary heart disease. Currently, there is …
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The use of bempedoic acid in treating hypercholesterolemia
… Though often regarded as relatively low risk and widely effective in treating hypercholesterolemia, statin therapy has a variety of limitations, including statin resistance and statin intolerance. These limitations have led researchers to actively investigate other types of …
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