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Full-Text Articles in Medicine and Health Sciences

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico Jun 2022

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …


Cancer-Targeting Immunostimulatory Peptides As An Immunotherapeutic Approach To Cancer, Rachel Montel Aug 2020

Cancer-Targeting Immunostimulatory Peptides As An Immunotherapeutic Approach To Cancer, Rachel Montel

Seton Hall University Dissertations and Theses (ETDs)

This dissertation reports the synthesis and biological applications of bifunctional trimeric peptides with B7H6-derived NKp30 binding motifs that serve to activate an immunocytotoxic response in natural killer cells and a GRP78-binding motif that can target tumors that express surface GRP78. In this manner the cancer-targeting immunostimulatory peptides are anticipated to directly bind and activate effector NK92-MI cells while also recognizing and binding to target A549 tumor cells to facilitate NK cell-dependent immunocytotoxicity of the targeted tumors. The NKp30 binding peptide motifs are derived from the tumor associated B7H6 antigen that is often downregulated or shed from the surface of tumors …


Understanding Elements Involved In Active Racial And Ethnic Minority Recruitment Practices For Biopharmaceutical-Sponsored Clinical Trials: A Socio-Ecological Qualitative Inquiry, Rebecca Rae Johnson May 2020

Understanding Elements Involved In Active Racial And Ethnic Minority Recruitment Practices For Biopharmaceutical-Sponsored Clinical Trials: A Socio-Ecological Qualitative Inquiry, Rebecca Rae Johnson

Seton Hall University Dissertations and Theses (ETDs)

Inequitable participation in clinical trials continues to be a problem, and trial populations do not always reflect the demographics of the population that the investigational product will ultimately be treating. Because genetic differences between racial and ethnic groups affect the safety and efficacy of new treatments, it is important that standard of care decisions are made based on a representative population. The purpose of this study is to understand the socio-ecological elements that are involved in the active implementation of racial and ethnic minority recruitment practices for biopharmaceutical-funded trials in the United States. This general qualitative study was both descriptive …


Meta-Analysis To Identify And Evaluate Factors Associated With Regulatory Approval Of Orphan Drugs (Od) To Develop An Algorithm For Predicting Regulatory Approval (Success) And To Develop A Standardized Tool To Improve Orphan Drug Portfolio Decision-Making, Milky C. Florent Mar 2019

Meta-Analysis To Identify And Evaluate Factors Associated With Regulatory Approval Of Orphan Drugs (Od) To Develop An Algorithm For Predicting Regulatory Approval (Success) And To Develop A Standardized Tool To Improve Orphan Drug Portfolio Decision-Making, Milky C. Florent

Seton Hall University Dissertations and Theses (ETDs)

Background and Purpose of the Study: Developed an algorithm (AODI) for predicting probability of regulatory success (PRS) for new orphan drugs after phase II testing has been conductedwith the objective of providing a tool to improve drug portfolio decision-making.Methods: Examined 132 studies from recent publications (2005 onwards). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Meta-analysis and meta-regressions were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors.Results: Found that a simple three-factor model (disease prevalence, clinical trial duration and clinical trial …


Site-Selective Modification Of Peptides And Proteins Via Organocatalyzed Henry Reaction, Zilma Pereira Muneeswaran May 2018

Site-Selective Modification Of Peptides And Proteins Via Organocatalyzed Henry Reaction, Zilma Pereira Muneeswaran

Seton Hall University Dissertations and Theses (ETDs)

In this research, peptides and protein containing serine on the N-terminus underwent site-selective modification following organocatalyzed bioconjugation that offered an additional functional group. It was shown that transforming the N-terminus serine to an aldehyde allowed site-specific bioconjugation to occur by utilizing the well-known Henry reaction. This method also grants a safer pathway for bioconjugation utilizing “green-chemistry” and biocompatible conditions. Amino acids and amino acid derived organocatalysts were utilized in the Henry reaction resulting in yields of up to 86 % conversion. Promising preliminary results were achieved in this research using peptides and myoglobin as the bioconjugation targets. Further investigation to …


B7h6: A Cancer Biomarker For The Development Of Novel Immunotherapy Approaches, Mariana Phillips May 2017

B7h6: A Cancer Biomarker For The Development Of Novel Immunotherapy Approaches, Mariana Phillips

Seton Hall University Dissertations and Theses (ETDs)

Cancer-based immunotherapy has led the evolution of biologics that can stimulate immune responses towards tumor eradication. The synthesis of small to intermediate size molecules with the targeting and effector functions of mAb may represent a novel class of immunotherapeutics that may overcome the limitations of their biological counterparts.Towards this objective, B7H6 has been identified as a protein ligand localized on the cell surface of transformed tumor cells. B7H6 binds specifically to the activating receptor NKp30, constitutively expressed on all resting and active NK cells. Upon ligand:receptor binding, B7H6 triggers NK cell activation and release of chemokines and pro-inflammatory cytokines such …


Rnai Nanotechnology: A Platform For Sirna Screening And Cancer Gene Therapy, Mayurbhai Ravikant Patel Aug 2016

Rnai Nanotechnology: A Platform For Sirna Screening And Cancer Gene Therapy, Mayurbhai Ravikant Patel

Seton Hall University Dissertations and Theses (ETDs)

Over the past two decades, advances in RNA structural biology have improved our understanding of the structures and folding properties of naturally occurring RNAs. RNA sequences and structures participate in many specific biological functions, such as those performed by messenger RNA (mRNA), ribosomal RNA (rRNA), transfer RNA (tRNA), micro RNA (miRNA), short-interfering RNA (siRNA), small nuclear RNA (snRNA) and many others. The noncoding RNAs, such as siRNA, do not express proteins but have been utilized in a wide range of applications, including RNA interference (RNAi) and the regulation of mRNA expression. These important biological functions have been implemented in gene …


Off-Label Prescribing: Pediatrician Beliefs And Experience, Elizabeth G. Evola May 2012

Off-Label Prescribing: Pediatrician Beliefs And Experience, Elizabeth G. Evola

Seton Hall University Dissertations and Theses (ETDs)

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Preliminary Studies Into Dna Binding Capabilities Of Ruthenium Nitro Nitrosyl As Anti-Tumor Pro-Drugs, Natasha Hansson Nov 2010

Preliminary Studies Into Dna Binding Capabilities Of Ruthenium Nitro Nitrosyl As Anti-Tumor Pro-Drugs, Natasha Hansson

Seton Hall University Dissertations and Theses (ETDs)

The complex [Ru(bpy)z(NO)(N02)](PF6)2 was investigated as a potential anti­ tumor drug option. The nitrosyl group was displaced by reaction with azide ion in acetone to yield the solvento complex in situ. The products isolated from addition of a solution or slurry of guanine, adenine, cytosine or thiamine to the resulting [Ru(bpy)(N02)(acetone)t were investigated by electronic absorption spectroscopy, infra­ 1 red spectroscopy, H NMR spectroscopy and cyclic voltammetry. The results of the studies showed that guanine, adenine and thiamine form adducts with Ru(bpy)z(N02)(acetone)t. However, each base forms a unique complex as shown by electronic spectroscopy. Guanine is the strongest field ligand, …


Analysis Of Residual Solvents In Pharmaceuticals By Comprehensive Two-Dimensional Gas Chromatography, Cristina Marie Crimi Jan 2008

Analysis Of Residual Solvents In Pharmaceuticals By Comprehensive Two-Dimensional Gas Chromatography, Cristina Marie Crimi

Seton Hall University Dissertations and Theses (ETDs)

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Chemical And Biochemical Modification Of Surfaces For Control Of Wettability, Adsorption, And Drug Delivery, Susan C. D'Andrea Jan 2005

Chemical And Biochemical Modification Of Surfaces For Control Of Wettability, Adsorption, And Drug Delivery, Susan C. D'Andrea

Seton Hall University Dissertations and Theses (ETDs)

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What Are The Elements Of A Successful Training Model, As Perceived By Global Corporate Security Heads Working In The Ethical Pharmaceutical Industry?, Kevin P. Schatzle Jan 2003

What Are The Elements Of A Successful Training Model, As Perceived By Global Corporate Security Heads Working In The Ethical Pharmaceutical Industry?, Kevin P. Schatzle

Seton Hall University Dissertations and Theses (ETDs)

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Retirees And Pharmaceutical Costs: Is There Really A Crisis?, Justine Maiello Jul 2002

Retirees And Pharmaceutical Costs: Is There Really A Crisis?, Justine Maiello

Seton Hall University Dissertations and Theses (ETDs)

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Building And Growing Customer Communications: A Framework For Exploring Commonalities And Differences In The Ways Consumers Are Targeted With Health Care Messages By Multinational Pharmaceutical Companies In Europe And In The United States, Gail S. Thornton Jan 2002

Building And Growing Customer Communications: A Framework For Exploring Commonalities And Differences In The Ways Consumers Are Targeted With Health Care Messages By Multinational Pharmaceutical Companies In Europe And In The United States, Gail S. Thornton

Seton Hall University Dissertations and Theses (ETDs)

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Perceptions Regarding Knowledge Management: An Exploration Of Characteristics And Components Of Knowledge Management With Application In The Pharmaceutical Industry, Michael D. Sutch Jan 1999

Perceptions Regarding Knowledge Management: An Exploration Of Characteristics And Components Of Knowledge Management With Application In The Pharmaceutical Industry, Michael D. Sutch

Seton Hall University Dissertations and Theses (ETDs)

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