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Patterns Of Regularity Noncompliance Identified By The U.S. Food And Drug Administration And Their Effects On Meta-Analyses, Craig A. Garmendia Sep 2018

Patterns Of Regularity Noncompliance Identified By The U.S. Food And Drug Administration And Their Effects On Meta-Analyses, Craig A. Garmendia

FIU Electronic Theses and Dissertations

The objective of this study was to determine the patterns of regulatory noncompliance, as identified by the U.S. Food and Drug Administration (FDA), and their effects on meta-analyses. In order to achieve these objective, three studies were undertaken: analysis of citations issued by FDA Investigators at the conclusion of an inspection; analysis of regulatory actions taken by the FDA towards clinical researchers based on the observations cited by FDA Investigators; and sensitivity analysis of meta-analyses based on the Agency’s determination of research misconduct, primarily the falsification of data. FDA Investigator citations were analyzed using Chi-Square analysis based on geographic location …


Elucidating The Role Of Neighborhood Deprivation In Hypertensive Disorders Of Pregnancy, Kelly M. Winter Jun 2018

Elucidating The Role Of Neighborhood Deprivation In Hypertensive Disorders Of Pregnancy, Kelly M. Winter

FIU Electronic Theses and Dissertations

This dissertation examined risk factors for hypertensive disorders of pregnancy (HDP) — specifically whether neighborhood socioeconomic deprivation exacerbates individual socioeconomic disadvantage (deprivation amplification) to increase the likelihood of developing HDP. To select the optimal areal unit at which to investigate HDP, geographic proxies for neighborhoods were explored.

A thematic review qualitatively examined nontraditional neighborhood boundaries identified through internet sources. Data from 2008–2012 Miami-Dade County, Florida birth records (n=121,421) and the U.S. Census Bureau were used for the remaining analyses. Ordinary least squares (OLS) and geographically weighted regression (GWR) analysis empirically compared the proportion of HDP prevalence explained by six areal …


Exposure To Estrogenic Endocrine Disrupting Chemicals And Brain Health, Mark Preciados May 2018

Exposure To Estrogenic Endocrine Disrupting Chemicals And Brain Health, Mark Preciados

FIU Electronic Theses and Dissertations

The overall objective of this dissertation was to examine exposures to the estrogenic endocrine disrupting chemicals (EEDCs), phthalates, bisphenol-A (BPA), and the metalloestrogens cadmium (Cd), arsenic (As), and manganese (Mn) in an older geriatric aged-population and examine associations with brain health. Given the evidence that EEDCs affect brain health and play a role in the development of cognitive dysfunction and neurodegenerative disease, and the constant environmental exposure through foods and everyday products has led this to becoming a great public health concern. Using a bioinformatic approach to find nuclear respiratory factor 1 (NRF1) gene targets involved in mitochondrial dysfunction, that …