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 3 of 3 for “"FDA Adverse Event Reporting System"”.
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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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An Economic and Regulatory Analysis of Gene Therapy Products Authorized by the US Food and Drug Administration and the European Medicines Agency
… has recently 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 …
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Associating adverse drug effects with protein targets by integrating adverse event, in vitro bioactivity, and pharmacokinetic data
Adverse drug effects are unintended and undesirable effects of medicines, causing attrition of molecules in drug development and harm to patients. To anticipate potential adverse effects early, drug candidates are commonly screened for pharmacological activity against a panel of protein targets. …