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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

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 …

Impact Of A Lifestyle Modification Intervention On Health Behaviors And Health Outcomes In A Mexican American Population: A Mixed-Methods Study, Ramandeep Kaur

FIU Electronic Theses and Dissertations

Metabolic syndrome (MetS), a global public health problem, is the primary cause of type 2 diabetes and cardiovascular disorders. Lifestyle modification interventions (dietary and physical activity modifications) are effective in preventing and ameliorating MetS and associated comorbidities. However, the impact of lifestyle changes on MetS among Mexican Americans has yet to be investigated, particularly due to high attrition rates in this population.

The overall goal of the explanatory mixed-methods study presented in this dissertation was to identify efficacious lifestyle modification efforts directed towards Mexican Americans to promote their retention in lifestyle modification programs, ameliorate the severity of MetS, and understand …