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 100 for “"Food and Drug Administration (FDA)"”.
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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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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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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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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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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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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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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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Pharmacovigilance in Post-Marketing: Risk Assessment and Reporting Standards
<p>While there has been new targeted drug therapies released into the market over the recent years, pulmonary arterial hypertension (PAH) remains to be a rapidly progressive disease with poor prognosis. Over time the arteries stiffen and tighten subsequently leaving the heart to pump harder to try …
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Trends in U.S. regulatory approvals of the biopharmaceutical therapeutic entities
… by annual output of new molecular entities and new therapeutic biologics, has fallen significantly since reaching a peak in 1996. According to Food and Drug Administration (FDA) data, the number of new drug approvals (new molecular entities and new biologics) fell from 50 in 1996 to 29 in …
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Robust Post-donation Blood Screening under Limited Information
… essential components of any healthcare system, and their safety, in terms of being free of transfusion-transmittable infections, is crucial. While the Food and Drug Administration (FDA) in the United States requires all blood donations to be tested for a set of infections, it does not dictate …
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Antimicrobial Activity of Cannabis Extraction Products and Terpenes against Foodborne Pathogens And Use of Electrochemically Activated (ECA) Water for Control of Indoor Mold in a Cannabis Production Facility
Cannabis has been in the news a lot lately and food industries are coming up with innovative ideas every day to use cannabis in their products. To name a few new food and beverage products which have incorporated cannabis for flavor or medicinal purposes are beers, chocolates, cookies, and other …
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Mass Spectrometry Based Diagnostics for APRT Deficiency: A Validation of a UPLC-MS/MS Urinary Assay for Absolute Quantification of 2,8-dihydroxyadenine and Adenine
… með tilliti til verklagsreglna um gildingar frá food and drug administration (FDA). Úrvinnsla gagnanna var síðan framkvæmd með forritunum Masslynx, Targetlynx og Microsoft Excel. Sértæknimælingin tókst vel, lægsti mælanlegi styrkur var lækkaður niður í 50 ng/ml. Áreiðanleiki, nákvæmni, smit, …
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A NOVEL PIPELINE FOR DRUG DISCOVERY IN NEUROPSYCHIATRIC DISORDERS USING HIGH-CONTENT SINGLE-CELL SCREENING OF SIGNALLING NETWORK RESPONSES EX VIVO
… platform for the measurement of kinetic ligand responses across cell signalling networks at the single-cell level in distinct PBMC subtypes ex vivo. Using automated sample preparation, fluorescent cellular barcoding and flow cytometry the platform is capable of detecting 21, 840 parallel …
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Factors influencing the time for FDA review of medical devices
… must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application (PMA) is the process by which this occurs. Companies submit a PMA after they …
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Biomarker analysis for APRT deficiency diagnosis using UPLC-MS/MS
… the APRT enzyme is absent, adenine is oxidized and forms 2,8-dihydroxyadenine (DHA). DHA is insoluble in urine and can precipitate and form kidney stones, which can cause acute and chronic kidney failure. The disease can be treated with the drugs allopurinol and febuxostat, which prevent the …
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