Chemicals and Drugs Commons^™

Metformin And Vitamin B12 Deficiency: Consequences And Patient Monitoring, Kathryn Dietz

Physician Assistant Scholarly Project Posters

• The incidence of type 2 diabetes has been increasing at a rapid rate in the United States.

• Metformin is recommended as the first line treatment to be started at the time of diagnosis in all patients without contraindications and has been associated with vitamin B12 deficiency.

• There are currently no clinical guidelines for the routine monitoring of B12 levels in this population.

• The purpose of this scholarly project is to determine if there are consequences of this deficiency and to make recommendations for screening patients.

• It includes current research that focuses on the pathophysiology of …

The Association Between Antipsychotic Medication And Weight Gain, Brian Steen

Physician Assistant Scholarly Project Posters

• Antipsychotic medications are utilized for patients with many mental health problems including schizophrenia, attention deficit hyperactivity disorder, autism, bipolar mania, and psychotic depression. The antipsychotic medications treat the symptoms associated with these mental health disorders.

• Antipsychotic medications, while being efficacious to these symptoms, can have unwanted side effects, including weight gain. The purpose of this study was to determine if there is a strong relationship with antipsychotic medication use and weight gain.

• The review of literature was conducted with an online search of Cochrane, PubMed, and PsycInfo for journal articles, research studies, and other scholarly reviews. Articles …

Pharmacogenetic Testing In The Treatment Of Major Depressive Disorder, Brianna Strube

Physician Assistant Scholarly Project Posters

• Major depressive disorder (MDD) is one of the most prevalent psychiatric disorders in the United States and is a large cause of disability. Antidepressants take weeks/months to become effective which can lead to noncompliance. Treatment has a high failure rate which increases medical costs and leads to decreased patient outcomes.

• Pharmacogenetic testing is the practice of analyzing genetic differences to predict a patient’s response to medications to improve efficacy and decrease adverse side effects. The purpose of this study was to investigate if pharmacogenetic-guided treatment, specifically in the use of antidepressants in MDD, has resulted in improved patient …

Microbial Ecology Of Fresh Vegetables, J. Zheng, A. De Jesus, S. Sahu, A. E. Hayford, Y. Luo, A. R. Datta, E. W. Brown, R. Bell

United States Food and Drug Administration: Publications

The total consumption of fresh and processed vegetables has exceeded 123 kg per capita in the United States and 118 kg per capita in the European Union (http://www.helgilibrary.com/ indicators/index/vegetable‐consumption‐percapita) in 2009. Changes in lifestyles and consumption trends have prompted the sustained growth of fresh‐cut or minimally processed vegetables that are fresh and ready‐to‐eat (RTE). In 2011, for example, total US fresh‐cut produce sales through both food service and retail channels were estimated to surpass $27 billion (Cook et al., 2012).

Association Between Proton Pump Inhibitor Use & Dementia: A Two-Fold Approach, Lisa Steers

Physician Assistant Scholarly Project Posters

An observational study of data derived from the German Study on Aging, Cognition and Dementia indicated that proton pump inhibitor use was associated with dementia risk (Benmassaoud, McDonald, & Lee, 2016). The purpose of this study is to explore a two-fold approach between proton pump inhibitor use and dementia. This two-fold approach will first investigate the association between dementia and proton pump inhibitor use and secondly, the proposed pathophysiology behind it. This approach to proton pump inhibitor use and dementia will allow for providers to utilize the association and make decisions to avoid chronic proton pump inhibitor use in effort …

Risk Of Gastrointestinal Bleeding Among Dabigatran Users – A Self Controlled Case Series Analysis, Wenze Tang, Hsien-Yen Chang, Meijia Zhou, Sonal Singh

Epidemiology Faculty Publications

This article aims to evaluate the real world risk of gastrointestinal bleeding among users naïve to dabigatran. We adopted a self-controlled case series design. We sampled 1215 eligible adult participants who were continuous insured users between July 1, 2010 and March 31, 2012 with use of dabigatran and at least one gastrointestinal bleeding episode. We used a conditional Poisson regression to estimate incidence rate ratios. The population consisted of 64.69% of male and 60.25% patients equal to or greater than age 65 at start of observation. After adjustment for time-variant confounders, the incidence rate of gastrointestinal bleeding was similar during …

Combating Antibiotic Resistance: A Policy Roadmap To Reduce Use Of Medically Important Antibiotics In Livestock, Expert Commission On Addressing The Contribution Of Livestock To The Antibiotic Resistance Crisis 2017

Antibiotic Resistance Action Center (ARAC)

No abstract provided.

“Whatever It Takes To Beat Parkinson’S”: A Controversial Approach For Symptom Relief, Sondra M. Deskins

WRIT: Journal of First-Year Writing

It is known that there is no cure for Parkinson's disease. So, physicians who treat Parkinson's patients must decide what is the best treatment option for the patients symptoms to improve their quality of life. Currently, there are pharmaceutical options for treatment, but they include adverse side effects. What if there were a way to treat patients for the side effects as well as improve the patient's symptoms? The recent commotion around the legalization of marijuana, both recreational and medicinal, has caused interest among patients and physicians. One must decide if the benefits of using marijuana as a form of …

Steroids: A Growing Dilemma In Athletics, Seara Ontiveros

Nebraska College Preparatory Academy: Senior Capstone Projects

A comprehensive and straight forward description of what exactly steroids are and what they do to the body is described by Gary Wadler, a health major at the New York University School of Medicine, he comments: “When the receptor sites in their bodies, which don’t have much testosterone in them, suddenly are presented with a lot of testosterone, they get activated…The unbalance of hormones increases the red blood cell formations... They’ll get more muscular, more defined. They’ll lose some fat, and increase their lean body mass, [they’ll] get stronger”. Although anabolic steroids and other hormones are consumed by many athletes …

Unmasking Of Myoclonus By Lacosamide In Generalized Epilepsy, Daniel Birnbaum, Mohamad Z. Koubeissi

Neurology Faculty Publications

Lacosamide is a new-generation antiseizure medication that is approved for use as an adjunctive treatment and monotherapy in focal epilepsy. Its use in generalized epilepsy, however, has not been adequately evaluated in controlled trials. We report a 67-year-old woman who experienced new-onset myoclonic seizures after initiation of lacosamide. We presume that she had an undiagnosed generalized epilepsy syndrome, likely juvenile myoclonic epilepsy. Myoclonic seizures were not reported before introducing lacosamide and completely resolved after lacosamide was discontinued. This suggests that lacosamide may have the potential to worsen myoclonus, similar to what has been reported with another sodium channel agent, lamotrigine, …

Antibiotic Resistance And Diagnostic Tests: What You Need To Know, Antibiotic Resistance Action Center (Arac)

Antibiotic Resistance Action Center (ARAC)

No abstract provided.

Can A Layer Of Antimicrobial Agents Be Placed Around Breast Implants To Prevent Staph Infections From Occurring?, Valerie L. Tran

UROP Posters

The most common infection that occurs after breast augmentation is a staph infection. Currently, there are only three ways to treat this type of infection, all of which treat the breast implant after the infection has developed. The first option is to treat the infection with an oral antibiotic. If this doesn’t completely rid the infection, then intravenous antibiotics are used. If this too doesn’t remove the infection, then surgery will be performed to remove the breast implant and a new implant will be inserted. Although, these options have a low mortality rate, the success rate of completely getting rid …

Myeloperoxidase-Mediated Protein Lysine Oxidation Generates 2- Aminoadipic Acid And Lysine Nitrile In Vivo, Hongqiao Lin, Bruce S. Levison, Jennifer A. Buffa, Ying Huang, Xiaoming Fu, Zeneng Wang, Valentin Gogonea, Joseph A. Didonato, Stanley L. Hazen

Chemistry Faculty Publications

Recent studies reveal 2-aminoadipic acid (2-AAA) is both elevated in subjects at risk for diabetes and mechanistically linked to glucose homeostasis. Prior studies also suggest enrichment of protein-bound 2-AAA as an oxidative post-translational modification of lysyl residues in tissues associated with degenerative diseases of aging. While in vitro studies suggest redox active transition metals or myeloperoxidase (MPO) generated hypochlorous acid (HOCl) may produce protein-bound 2-AAA, the mechanism(s) responsible for generation of 2- AAA during inflammatory diseases are unknown. In initial studies we observed that traditional acid- or basecatalyzed protein hydrolysis methods previously employed to measure tissue 2-AAA can artificially generate …

Engineered Peptides For Applications In Cancer-Targeted Drug Delivery And Tumor Detection, R. Soudy, N. Byeon, Y. Raghuwanshi, S. Ahmed, A. Lavasanifar, Kamaljit Kaur

Pharmacy Faculty Articles and Research

Cancer-targeting peptides as ligands for targeted delivery of anticancer drugs or drug carriers have the potential to significantly enhance the selectivity and the therapeutic benefit of current chemotherapeutic agents. Identification of tumor-specific biomarkers like integrins, aminopeptidase N, and epidermal growth factor receptor as well as the popularity of phage display techniques along with synthetic combinatorial methods used for peptide design and structure optimization have fueled the advancement and application of peptide ligands for targeted drug delivery and tumor detection in cancer treatment, detection and guided therapy. Although considerable preclinical data have shown remarkable success in the use of tumor targeting …

Synthesis Of A 1,2,4-Substituted Imidazole For A Fragment-Based Drug Discovery Library, Tyler Lafferty

Honors Program Theses

The field of medicinal chemistry requires efficient, novel drug development processes to sustain and advance the landscape of current pharmaceutical agents. To this end, fragment-based drug discovery (FBDD) is a methodology that aims to provide a balanced approach to the hit detection and lead optimization stage in the identification of small molecule agents (fragments). These small, low-molecular weight (mw<300 amu) molecules are employed in various biochemical assays to identify leads against a biological target. One challenge in FBDD is the synthesis of novel fragments containing heterocycles with a selective synthetic handle, a functional group designed to allow further modification. Heterocyclic fragments that allow for straightforward synthesis and modification are underrepresented in fragment libraries and offer the intriguing opportunity for rapid diversification into a fragment library from single, heterocyclic parent fragment. The imidazole is a heterocycle that presents a unique synthetic challenge for organic chemists, as current imidazole syntheses do not allow for regioselective synthesis of a 1,2,4-substitued imidazole. The research herein describes the approaches taken towards the challenge of synthesizing the 1,2,4-substituted imidazole parent fragment containing a hydrophilic moiety, synthetic handle, and phenyl ring derivative.

Substituent Strength Vs Reactivity: A Study Of 1,3,4-Oxadiazoles And Electron Donating Groups, Katlynn Merringer

Undergraduate Honors Thesis Projects

This investigation focused on determining if there was a relationship between electron donating group substituent strength and resulting percent yield values of the 1,3,4-oxadiazole product. The data obtained from this investigation aimed to help chemists better understand the reactivity of the 1,3,4-oxadiazole because of its importance in the realm of drug design and development. In order to accomplish this, electron donating groups with varying pKa values were placed on the 1,3,4-oxadiazole and the resulting percent yields were analyzed for possible trends. The substituents used represented both resonance donating and inductively donating groups and were placed in both ortho and para …

Synthesis Of Oxadeazoles With Electron Withdrawing Groups And The Analysis Of Product Yield With Bond Length, Elizabeth Ann Hall Peters

Undergraduate Honors Thesis Projects

2,5-disubstituted 1,3,4-oxadiazoles are a class of organic compound that are widely used and successful in pharmaceutical chemistry because they demonstrate strong biological activity. They are part of a larger class of compound called heterocycles, which make up most pharmaceutical drugs today. When synthesizing the compounds, higher yield means higher reactivity of the compound, and this is important for pharmaceuticals that need to have a strong biological activity. Per past studies, electron withdrawing groups on the compound allow higher, product yields. Along with electron withdrawing group addition, the bond length from electron withdrawing group and its corresponding carbon is analyzed to …

Uvb Induces Mvp Release In A Paf Dependent Manner In Skin-Dervied Epithelial Cell Line, Langni Liu, Katherine E. Fahy, Christine M. Rapp, Eric J. Romer, Christina E. Borchers, Ji C. Bihl, Jeffrey B. Travers

Pharmacology and Toxicology Faculty Publications

Ultraviolet-B (UVB) irradiation of the skin can result in both acute inflammation and systemic immunosuppression. These effects are mediated by the release of bioactive molecules (e.g. cytokines and lipids) from resident skin epithelial and immune cells. Our lab has previously determined that UVB exposure stimulates the production of an inflammatory phospholipid activator, platelet-activating factor (PAF) and its oxidized analogs, which are involved in mediating the UVB responses. Due to the fact that UVB radiation is absorbed by the epidermis but causes systemic effects, we are interested in examining the PAF-mediated mechanisms of systemic intercellular communication. Microvesicle particles (MVP) are small …

Actionable Patient Safety Solution (Apss) #3d: Pediatric Adverse Drug Events, Ron Jordan, Jerika Lam, Nathaniel Sims, Anne Lyren, Coco Yang

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing a "program to reduce the incidence of pediatric adverse drug events (pADEs) and harm ... [that] combine[s] leadership strategies, software (healthcare IT), hardware (drug compounding systems, drug delivery technology, and physiological monitoring systems), and most importantly people (changes in clinical practice, protocols and education)" to protect pediatric patients.

The Autocrine Role Of Proteoglycan-4 (Prg4) In Modulating Osteoarthritic Synoviocyte Proliferation And Expression Of Matrix Degrading Enzymes, Ali Alquraini, Maha Jamal, Ling Zhang, Tannin Schmidt, Gregory D. Jay, Khaled A. Elsaid

Pharmacy Faculty Articles and Research

Background: Lubricin/proteoglycan 4 (PRG4) is a mucinous glycoprotein secreted by synovial fibroblasts and superficial zone chondrocytes. Recently, we showed that recombinant human PRG4 (rhPRG4) is a putative ligand for CD44 receptor. rhPRG4-CD44 interaction inhibits cytokine-induced rheumatoid arthritis synoviocyte proliferation. The objective of this study is to decipher the autocrine function of PRG4 in regulating osteoarthritic synoviocyte proliferation and expression of catabolic and pro-inflammatory mediators under basal and interleukin-1 beta (IL-1β)- stimulated conditions.

Methods: Cytosolic and nuclear levels of nuclear factor kappa B (NFκB) p50 and p65 subunits in Prg4+/+ and Prg4-/- synoviocytes were studied using western blot. Nuclear …

Rationale For, Initiation And Titration Of The Basal Insulin/Glp-1ra Fixed-Ratio Combination Products, Ideglira And Iglarlixi, For The Management Of Type 2 Diabetes, Virginia Valentine, Jennifer Goldman, Jay H. Shubrook

Faculty Publications & Research of the TUC College of Osteopathic Medicine

Type 2 diabetes (T2D) is a progressive disease affecting glucose regulation and a major cause of morbidity and mortality globally. Many patients are not escalated up the treatment ladder appropriately despite failing to achieve glycemic control, with barriers such as fear of hypoglycemia, weight gain, and treatment burden recognized as factors. Exogenous basal insulin is titrated to address control of fasting plasma glucose and may preserve residual β-cell function, thus promoting a greater endogenous prandial insulin response. Native glucagon-like peptide-1 (GLP-1) is a peptide hormone secreted by the gut in response to nutrient ingestion; it increases insulin secretion, inhibits glucagon …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

Enhanced Potency Of Bivalent Small Molecule Gp41 Inhibitors, Vladimir Sofiyev, Hardeep Kaur, Beth A. Snyder, Priscilla A. Hogan, Roger G. Ptak, Peter Hwang, Miriam Gochin

Faculty Publications & Research of the TUC College of Osteopathic Medicine

Low molecular weight peptidomimetic inhibitors with hydrophobic pocket binding properties and moderate fusion inhibitory activity against HIV-1 gp41-mediated cell fusion were elaborated by increasing the available surface area for interacting with the heptad repeat-1 (HR1) coiled coil on gp41. Two types of modifications were tested: 1) increasing the overall hydrophobicity of the molecules with an extension that could interact in the HR1 groove, and 2) forming symmetrical dimers with two peptidomimetic motifs that could potentially interact simultaneously in two hydrophobic pockets on the HR1 trimer. The latter approach was more successful, yielding 40–60 times improved potency against HIV fusion over …

Actionable Patient Safety Solution (Apss) #3a: Medication Errors, Ron Jordan, Jerika Lam, Anne Lyren, Nathaniel Sims, Coco Yang

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing a program to reduce medication errors, which are a major cause of patient morbidity and mortality.

Recent Analytical Methods For The Analysis Of Sweeteners In Food: A Regulatory Perspective, Romina Shah, Lowri S. De Jager

United States Food and Drug Administration: Publications

Non-nutritive or low calorie sweeteners are commonly used worldwide in the food industry, often in combination in order to limit undesirable tastes. The list of allowable sweeteners varies among countries and it is important for regulatory agencies and food safety laboratories to monitor these highly consumed products to ensure compliance with worldwide regulations. Current analytical methods for confirmation and quantification of sweeteners must allow for confirmation of analyte identity in order to be compatible with today’s standards. Various methods for the determination of non-nutritive sweeteners have been reported in the literature. Th e most common multi-sweetener methods involve high performance …

Cannabinoid Disposition In Oral Fluid After Controlled Smoked, Vaporized, And Oral Cannabis Administration, Madeleine J. Swortwood, Matthew N. Newmeyer, Maria Andersson, Osama A. Abulseoud, Karl B. Scheidweiler, Marilyn A. Huestis

United States Food and Drug Administration: Publications

Oral fluid (OF) is an important matrix for monitoring drugs. Smoking cannabis is common, but vaporization and edible consumption also are popular. OF pharmacokinetics are available for controlled smoked cannabis, but few data exist for vaporized and oral routes. Frequent and occasional cannabis smokers were recruited as participants for four dosing sessions including one active (6.9% Δ⁹-tetrahydrocannabinol, THC) or placebo cannabis-containing brownie, followed by one active or placebo cigarette, or one active or placebo vaporized cannabis dose. Only one active dose was administered per session. OF was collected before and up to 54 (occasional) or 72 (frequent) h …

Certain Dyes As Pharmacologically Active Substances In Fish Farming And Other Aquaculture Products, Eric Verdon, Wendy C. Andersen

United States Food and Drug Administration: Publications

The last 40 years have brought enormous changes to the aquaculture industry. The farming of fish and of seafood products has been continuously increasing from 3.9% by weight in 1970 to 36% in 2006 according to theWorld Health Organization (WHO) and Food and Agriculture Organization (FAO) of the United Nations.¹ The global trend of aquaculture development gaining importance in total fish supply has remained uninterrupted. Farmed food fish contributed a record 42.2% of the total 158 million tonnes of fish produced by capture fisheries and aquaculture in 2012 (Figure 9.1). This compares with just 13.4% in 1990 and 25.7% …

Color And Power Doppler Combined With Fetal Intelligent Navigation Echocardiography (Fine) To Evaluate The Fetal Heart, L. Yeo, R. Romero

United States Food and Drug Administration: Publications

Objective To evaluate the performance of color and bidirectional power Doppler ultrasound combined with Fetal Intelligent Navigation Echocardiography (FINE) in examining the fetal heart.

Methods A prospective cohort study was conducted of fetuses in the second and third trimesters with a normal heart or with congenital heart disease (CHD). One or more spatiotemporal image correlation (STIC) volume datasets, combined with color or bidirectional power Doppler (S-flow) imaging, were acquired in the apical four-chamber view. Each successfully obtained STIC volume was evaluated by STICLoop™ to determine its appropriateness before applying the FINE method. Visualization rates for standard fetal echocardiography views using …

Salmonella Inactivation During Extrusion Of An Oat Flour Model Food, Nathan M. Anderson, Susanne E. Keller, Niharika Mishra, Shannon Pickens, Dana Gradl, Tim Hartter, Galen Rokey, Christopher Dohl, Brian Plattner, Stuart Chirtel, Elizabeth M. Grasso-Kelley

United States Food and Drug Administration: Publications

Little research exists on Salmonella inactivation during extrusion processing, yet many outbreaks associated with low water activity foods since 2006 were linked to extruded foods. The aim of this research was to study Salmonella inactivation during extrusion of a model cereal product. Oat flour was inoculated with Salmonella enterica serovar Agona, an outbreak strain isolated from puffed cereals, and processed using a single-screw extruder at a feed rate of 75 kg/h and a screw speed of 500 rpm. Extrudate samples were collected from the barrel outlet in sterile bags and immediately cooled in an ice–water bath. Populations were determined using …

An Overview Of The Role Of Mathematical Models In Implementation Of Quality By Design Paradigm For Drug Development And Manufacture, Sharmista Chatterjee, Christine M.V. Moore, Moheb M. Nasr

United States Food and Drug Administration: Publications

A model is a representation of an underlying physical–chemical phenomenon. In the pharmaceutical industry, mathematical‐based models can be applied at all stages of development, starting with formulation design, continuing through process development and scale‐up, and extending into process monitoring and control of the commercial process. Implementation of models offers many benefits. These include, but are not limited to, (i) enhanced process understanding, (ii) reduction of experimentation cost, and (iii) improvement of productivity and product quality.

Models can be broadly categorized as either qualitative or quantitative. The focus of this chapter is quantitative models. These can be classified into three broad …