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Full-Text Articles in Medicine and Health Sciences
Immunoglobulin Therapy And Primary Immunodeficient Patients' Health-Related Quality Of Life And Well-Being, Niedre Heckman
Immunoglobulin Therapy And Primary Immunodeficient Patients' Health-Related Quality Of Life And Well-Being, Niedre Heckman
Walden Dissertations and Doctoral Studies
Individuals born with primary immune deficiency diseases (PIDD) have a dysfunctional immune system, and many are treated by lifelong injections of immunoglobulin therapy. Studies have shown that these patients have low health-related quality of life (HRQOL) and well-being (WB) and that these outcomes might be improved by the availability of therapy innovated according to preferences for fewer needle sticks or a shorter infusion time. Regulators at the U.S. Food and Drug Administration (FDA) have approved therapies innovated per these preferences. However, there is limited data demonstrating how these innovations impact HRQOL and WB. Using the biopsychosocial model, the purpose of …
Strategies For Compliance With Government Regulations In A Pharmaceutical Company, Charles Jagun
Strategies For Compliance With Government Regulations In A Pharmaceutical Company, Charles Jagun
Walden Dissertations and Doctoral Studies
Pharmaceutical companies accrued fines of over $30 billion within 25 years because of noncompliance with regulations. Noncompliance with regulations results in fines and an adverse impact on company profitability. Some pharmaceutical company managers lack effective strategies to ensure overall company compliance with regulation. Based on complexity leadership theory, the purpose of this single case study was to explore strategies pharmaceutical company managers used to ensure compliance with regulatory requirements in Nigeria. The target population was functional managers purposely selected because they had successfully implemented strategies for compliance with the regulatory requirements in Nigeria. Data were collected through face-to-face and telephone …
Under-Reporting Of Adverse Drug Reactions To The Food & Drug Administration, James Alexander Lamb
Under-Reporting Of Adverse Drug Reactions To The Food & Drug Administration, James Alexander Lamb
Walden Dissertations and Doctoral Studies
This study examined the potential significant differences in the distribution of adverse drug reactions (ADRs) by reporter (consumer versus physician) and patient outcome at case and event level. This study also contains exploratory questions to evaluate reporting of ADRs by consumers versus physician by system organ class (SOC) and reporter demographics within the United States Food & Drug Administration Adverse Event Reporting System (FAERS). The theoretical foundation applied in this quantitative study was the social amplification of risk framework. Data from the second quarter of 2016 were obtained from FAERS, and a total of 87,807 ADR reports corresponding to 143,399 …