Medicine and Health Sciences Commons^™

Current Analytical Techniques For Food Lipids, Cynthia T. Srigley, Magdi M. Mossoba

United States Food and Drug Administration: Publications

Thee analysis of food lipids presents significant challenges due to the wide variety of sample matrices, large range of total fat contents, and complex compositions of fatty acids. This is chapter reviews conventional analytical techniques for the quantification of total fat and fatty acids in foods and food ingredients, including the gravimetric determination of total fat, the calculation of fat and fatty acids using gas chromatography (GC), and the analysis of proximates content (i.e., fat, protein, carbohydrate, moisture, and ash) by Fourier transform infrared (FTIR) spectroscopy. Current official methods of analysis are evaluated and the use of certified reference materials …

Multiple Imputation To Evaluate The Impact Of An Assay Change In National Surveys, Maya Sternberg

United States Food and Drug Administration: Publications

National health surveys, such as the National Health and Nutrition Examination Survey, are used to monitor trends of nutritional biomarkers. These surveys try to maintain the same biomarker assay over time, but there are a variety of reasons why the assay may change. In these cases, it is important to evaluate the potential impact of a change so that any observed fluctuations in concentrations over time are not confounded by changes in the assay. To this end, a subset of stored specimens previously analyzed with the old assay is retested using the new assay. These paired data are used to …

Rapid Testing Of Food Matrices For Bacillus Cereus Enterotoxins, Sandra M. Tallent, Jennifer M. Hait, Ann M. Knolhoff, Reginald W. Bennett, Thomas S. Hammack, Timothy R. Croley

United States Food and Drug Administration: Publications

Nine different food products frequently associated with Bacillus cereus outbreaks were chosen as representative matrices to be evaluated with end-point polymerase chain reaction (PCR), enzyme linked immunosorbent assay, lateral flow device and mass spectrometry for detection of enterotoxins associated with human illness. Testing was performed on food portions inoculated with a bacterial strain and incubated at 30C for either 5 h or 24 h. A screening end-point multiplex PCR targeting enterotoxin genes including the emetic toxin and three diarrheal toxins, hemolytic hemolysin BL (Hbl), nonhemoltyic enterotoxin (Nhe), and cytolysin K. Commercially available kits were used to determine the presence/absence of …

Antiemetic Use Among Pregnant Women In The United States: The Escalating Use Of Ondansetron, Lockwood G. Taylor, Steven T. Bird, Leyla Sahin, Melissa S. Tassinari, Patty Greene, Marsha E. Reichman, Susan E. Andrade, Katherine Haffenreffer, Sengwee Toh

United States Food and Drug Administration: Publications

Purpose To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births.

Methods We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation.

Results In over 2.3 million …

Food Safety Traceability, Yimin Wei, Boli Guo, Hongyan Liu, Shuai Wei, Jianrong Zhang

United States Food and Drug Administration: Publications

With globalized economics, it is becoming more frequent to trade food across country and regional borders, which leads to expanding and spreading of all kinds of food safety incidents and hazards. Mad cow disease, foot and mouth disease, avian flu and other zoonotic diseases pose a grave threat to food safety and human health, causing serious economic losses for food industries and causing social panic at the same time. In order to reduce the losses caused by such serious zoonotic diseases, as well as to ensure food safety, many countries have started to implement food safety traceability systems. The European …

Quality By Design: Process Trajectory Development For A Dynamic Pharmaceutical Coprecipitation Process Based On An Integrated Real‐Time Process Monitoring Strategy, Huiquan Wu, Mansoor A. Khan

United States Food and Drug Administration: Publications

Increasing prevalence of poorly water‐soluble drugs in pharmaceutical development provides notable risks of new products demonstrating low and erratic bioavailability. This dissolution‐limited bioavailability may have consequences for safety and efficacy, particularly for drugs delivered by the oral route of administration. Several novel drug delivery technologies have been developed to improve drug solubility, dissolution rates, and bioavailability. Among those are solid dispersion, nanotechnology, supercritical fluid technology, lipid‐based technology, and crystal engineering. Although these strategies are available for enhancing the bioavailability of drugs with low aqueous solubility, the success of these approaches is not yet guaranteed and is greatly dependent on the …

The Impact Of The Boxed Warning On The Duration Of Use For Depot Medroxprogesterone Acetate, Efe Eworuke, Joo-Yeon Lee, Lisa Soule, Vaishali Popat, David G. Moeny

United States Food and Drug Administration: Publications

Objective The objective of this study was to examine the impact of the Food and Drug Administration’s boxed warning on the utilization of depot medroxyprogesterone (DMPA).

Methods From the IMS Lifelink data (2001–2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90- day DMPA or 30-day CHC between claims. Days’ supply (CHC) and 90-day duration (DMPA) was used to determine episodes. We used interrupted time series to evaluate changes in the mean episode …

Modeling And Statistical Issues Related To Salmonella In Low Water Activity Foods, Sofia M. Santillana Farakos, Michelle Danyluk, Donald Schaffner, Régis Pouillot, Linda J. Harris, Bradley P. Marks

United States Food and Drug Administration: Publications

The presence and survival of Salmonella in low water activity (a_w) foods continues to pose a challenge for the food industry. Peer‐reviewed literature data on prevalence and levels of contamination of Salmonella in low water activity foods in the United States are limited. Available published data include those on: Salmonella contamination on nuts and peanuts (Calhoun et al., 2013), almonds (Danyluk et al., 2007; Bansal et al., 2010), pecans (Brar, Strawn, and Danyluk, 2016), and walnuts (Davidson et al., 2015); prevalence and levels of Salmonella on spices (Van Doren et al., 2013); as …

Disparities In Hypertension And Cardiovascular Disease In Blacks: The Critical Role Of Medication Adherence, Keith C. Ferdinand, Kapil Yadav, Samar A. Nasser, Helene D. Clayton-Jeter, John Lewin, Dennis R. Cryer, Fortunato Fred Senatore

United States Food and Drug Administration: Publications

Blacks are two to three times as likely as whites to die of preventable heart disease and stroke. Declines in mortality from heart disease have not eliminated racial disparities. Control and effective treatment of hypertension, a leading cause of cardiovascular disease, among blacks is less than in whites and remains a challenge. One of the driving forces behind this racial/ethnic disparity is medication nonadherence whose cause is embedded in social determinants. Eight practical approaches to addressing medication adherence with the potential to attenuate disparities were identified and include: (1) patient engagement strategies, (2) consumer-directed health care, (3) patient portals, (4) …

Current Practices In Corrosion, Surface Characterization, And Nickel Leach Testing Of Cardiovascular Metallic Implants, Srinidhi Nagaraja, Matthew Di Prima, David Saylor, Erica Takai

United States Food and Drug Administration: Publications

In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In …

High Throughput Quantification Of Apolipoproteins A-I And B-100 By Isotope Dilution Ms Targeting Fast Trypsin Releasable Peptides Without Reduction And Alkylation, Bryan A. Parks, David M. Schieltz, Michael L. Andrews, Michael S. Gardner, John C. Rees, Christopher A. Toth, Jeffrey I. Jones, Lisa G. Mcwilliams, Zsuzsanna Kuklenyik, James L. Pirkle, John R. Barr

United States Food and Drug Administration: Publications

Purpose: Apolipoprotein A-I (ApoA-I) and apolipoprotein B-100 (ApoB-100) are amphipathic proteins that are strong predictors of cardiovascular disease risk. The traceable calibration of apolipoprotein assays is a persistent challenge, especially for ApoB-100, which cannot be solubilized in purified form.

Experimental design: A simultaneous quantitation method for ApoA-I and ApoB-100 was developed using tryptic digestion without predigestion reduction and alkylation, followed by LC separation coupled with isotope dilution MS analysis. The accuracy of the method was assured by selecting structurally exposed signature peptides, optimal choice of detergent, protein: enzyme ratio, and incubation time. Peptide calibrators were value assigned by isobaric tagging …

Pathophysiological Relevance Of Astroglial Angiotensin And The Endocannabinoid Signaling Systems In Shrs, Dhanush Haspula

Student Theses, Dissertations and Capstones

BACKGROUND: Spontaneously hypertensive rats (SHRs), an essential hypertension model, are characterized by pro-inflammatory states in brainstems. While Angiotensin (Ang) II, via activation of glial Ang Type 1 receptors (AT1Rs), has been shown to trigger a significant upsurge in pro-inflammatory cytokines, activation of astroglial Cannabinoid Type 1 Receptors (CB1Rs), elicits a potent anti-inflammatory response in the brain. Both brainstem AT1Rs and CB1Rs have also been reported to alter cardiovascular parameters in SHRs. Evidence of crosstalk between CB1Rs and AT1Rs has also emerged, further highlighting a need to understand their signaling interaction in cardiovascular diseases. APPROACH: The purpose of this study was …

Measuring Knowledge And Attitudes Regarding The Use Of Pharmacogenetic Testing Among Patients And Prescribers: Diffusion Of Innovation Theory, Suhaib Mohammad Muflih

Student Theses, Dissertations and Capstones

Background: Healthcare providers play a key role in patient care. Their knowledge and attitudes may play a critical role in the incorporation of pharmacogenetic (PGx) testing into routine practice. The knowledge and attitudes of patients are also equally important in determining the rate of diffusion and the adoption of PGx testing. This study aims to test Rogers’s diffusion of innovation theory to identify and evaluate the influence of knowledge, attitudes, and sociodemographic characteristics of patients and physicians on the adoption of PGx testing in current clinical settings. Method: A cross-sectional, descriptive survey design was implemented. The sample consisted of patients …

Chronic Health Conditions As A Risk Factor For Falls Among The Community-Dwelling Us Older Adults: A Zero-Inflated Regression Modeling Approach, Yoshita Paliwal, Patricia W. Slattum, Scott M. Ratliff

Pharmacotherapy and Outcomes Science Publications

Falls are an important health concern among older adults due to age-related changes in the body. Having a medical history of chronic health condition may pose even higher risk of falling. Only few studies have assessed a number of chronic health conditions as risk factor for falls over a large nationally representative sample of US older adults. In this study, Behavioral Risk Factor Surveillance System (BRFSS) 2014 participants aged 65 years and older (n = 159,336) were evaluated. It was found that 29.7% (n = 44,550) of the sample experienced at least one fall and 16.3% (n = 20,444) …

Evaluating Prescribing Patterns Of Long-Acting Injectable Antipsychotics At A Community Health System, Chelsea L Ferguson Pharmd, Jamie Gaul Pharmd, Bcps, Jared Netley Pharmd

Parkview Pharmacy Department

2017 ASHP Midyear Clinical Meeting / Orlando, Florida / Poster 10-084

Poster Presentation

Objective: Describe prescribing patterns for long-acting injectable antipsychotics and identify knowledge gaps in prescribing within our health system.

The Value Driven Pharmacist: Basics Of Access, Cost And Quality, Carriann Smith, Annette Mcfarland, Chad Knoderer, Joseph Jordan, Trish Devine, Jessica Wilhoite

Butler University Books

No abstract provided.

Components In Aqueous Hibiscus Rosa-Sinensis Flower Extract Inhibit In Vitro Melanoma Cell Growth, Karina H. Goldberg, Ariel C. Yin, Archana Mupparapu, Edward P. Retzbach, Gary S. Goldberg, Catherine F. Yang

College of Science & Mathematics Departmental Research

Skin cancer is extremely common, and melanoma causes about 80% of skin cancer deaths. In fact, melanoma kills over 50 thousand people around the world each year, and these numbers are rising. Clearly, standard treatments are not effectively treating melanoma, and alternative therapies are needed to address this problem. Hibiscus tea has been noted to have medicinal properties, including anticancer effects. Extracts from Hibiscus have been shown to inhibit the growth of a variety of cancer cells. In particular, recent studies found that polyphenols extracted from Hibiscus sabdariffa by organic solvents can inhibit melanoma cell growth. However, effects of aqueous …

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).

Annual Report - 2016-2017, Bill Gatton College Of Pharmacy, East Tennessee State University

GattonRX Magazine

No abstract provided.

College Of Pharmacy And Allied Health Professions, South Dakota State University

Jackrabbits Script and Scope (Formerly called College of Pharmacy and Allied Health Professions Magazine)

[Page] 2 A day in the life—The medical laboratory science program as seen through the eyes of second year student Brittany Kramer.
[Page] 4 What makes MLS special?—After being presented their white lab coats, medical laboratory science students share what drew them to the program.
[Page] 6 Meet the president—Allyson Helms, a P1 student from Waseca, Minnesota, is only the second pharmacy student to serve as president of the Students’ Association.
[Page] 8 Balance—Internationally known professor tells students about his professional achievements and discovering a work/life balance.
[Page] 10 Scholarship planning • Joye Ann Billow—Legacy of pioneering faculty member continues …

Impaired Myocardial Relaxation With Exercise Determines Peak Aerobic Exercise Capacity In Heart Failure With Preserved Ejection Fraction, Cory Trankle, Justin M. Canada, Leo Buckley, Salvatore Carbone, Dave Dixon, Ross Arena, Benjamin Van Tassell, Antonio Abbate

Pharmacotherapy and Outcomes Science Publications

Background

Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome characterized by impaired exercise capacity due to shortness of breath and/or fatigue. Assessment of diastolic dysfunction at rest and with exercise may provide insight into the pathophysiology of exercise intolerance in HFpEF.

Aims

To measure echocardio-Doppler-derived parameters of diastolic function as they relate to various indices of aerobic exercise capacity in HFpEF.

Methods

We selected 16 subjects with clinically stable HFpEF, no evidence of volume overload, but impaired functional capacity by cardiopulmonary exercise testing [peak oxygen consumption (VO₂)]. We measured the transmitral E and A flow …

Resting State Functional Network Disruptions In A Kainic Acid Model Of Temporal Lobe Epilepsy., Ravnoor Singh Gill, Seyed M Mirsattari, L Stan Leung

Physiology and Pharmacology Publications

We studied the graph topological properties of brain networks derived from resting-state functional magnetic resonance imaging in a kainic acid induced model of temporal lobe epilepsy (TLE) in rats. Functional connectivity was determined by temporal correlation of the resting-state Blood Oxygen Level Dependent (BOLD) signals between two brain regions during 1.5% and 2% isoflurane, and analyzed as networks in epileptic and control rats. Graph theoretical analysis revealed a significant increase in functional connectivity between brain areas in epileptic than control rats, and the connected brain areas could be categorized as a limbic network and a default mode network (DMN). The …

2017 Pharmacy Yearbook Top Notch, Touro College Of Pharmacy

Touro Yearbooks

Top Notch, the 2017 yearbook for the Touro College of Pharmacy

Synthesis And Characterization Of Ph/Temperature Dual Sensitive Multiblock Copolymer For Drug Delivery, Hyung Kyung Lee

Electronic Theses and Dissertations

The objective of this study was to develop a novel multiblock copolymer (MBCP) with temperature/pH dual-sensitivity which undergoes gelation at body temperature and degradation at acidic pH for controlled drug delivery applications. The MBCP with molecular weight of 42000 Da was synthesized by polycondensation between an acid-labile ketal linker, 2,2-bis(aminoethoxy)propane (BAP) and Pluronic® P104 using L-lysine diisocyanate ethyl ester (LDI) or 1,6-Diisocyanatohexane (HDI). The gelation temperature of 20% (w/v) MBCP was in the range of 29 to 31 ºC when tested with three different techniques: rheometer, test tube inversion method, and falling ball method. The polymer shopH-triggered degradation and drug …

Risk Of Medication Errors In The Home: An Integrative Literature Review, Maria M. Crescenzi

Honors Undergraduate Theses

Regardless of the setting, medication errors are of great concern when associated with an individual’s health outcomes, along with the increased costs to society, healthcare institutions, and providers. Current research focuses on medication error data primarily in acute and extended care facilities. However, there is a paucity of research examining the causes of medication errors that occur post hospital discharge when individuals transition to the home. The purpose of this integrative literature review is to examine risk factors for medication errors outside of these settings, specifically in the home. A systematic literature search was conducted using multiple databases for relevant …

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 …

Burden Of Illness And Pharmacoeconomic Evaluation Of Lumacaftor/Ivacaftor In Cystic Fibrosis, Pratyusha Vadagam

Electronic Theses and Dissertations

Objectives: (1) To estimate the burden of illness in cystic fibrosis (CF) using 2010-2014 Medical Expenditure Panel Survey (MEPS) data, and (2) to conduct a pharmacoeconomic evaluation of lumacaftor/ivacaftor in the treatment of CF.

Methods: The study was conducted in two parts. Part 1 involved a retrospective analysis using individuals in MEPS database with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code of 277.00 for a principal diagnosis of CF. Dependent variables were cumulative and out-of-pocket (OOP) expenditures and independent variables included patient demographics and clinical characteristics. Unweighted and weighted estimates of expenditure in CF group, …

Role Of Jagged1 In The Enrichment Of Cancer Stem Cells In Her2+ Breast Cancer, Deep Shah

Dissertations

Purpose: Breast cancer is the second leading cause of cancer-related deaths among women worldwide. Human Epidermal Growth Factor Receptor 2 (HER2) positive subtype of breast cancer is driven by a subpopulation of cells possessing stem cell properties of self-renewal and differentiation, known as Cancer Stem Cells (CSCs). CSCs are implicated in tumor growth as well as radiotherapy and chemotherapy associated resistance. Notch receptors promote breast CSCs survival and self-renewal, and overexpression of Notch ligand Jagged1 predicts poor prognosis. We showed previously that Notch could be an important target in trastuzumab/lapatinib resistant HER2+ breast cancer.

Experimental Design: Here, we sought to …

Actionable Patient Safety Solution (Apss) #3c: Improve Prevention Of Severe Hypoglycemia, Jerika Lam, Steven Barker, Michael Ramsay, Ariana Longley, Joe Kiani

Pharmacy Faculty Articles and Research

This report presents a plan of action for introducing a "program to reduce errors in the recognition and treatment of [severe hypoglycemia]".

The Application Of Half-Life In Clinical Decision Making: Comparison Of The Pharmacokinetics Of Extended-Release Topiramate (Usl255) And Immediate-Release Topiramate, Barry E. Gidal, Annie M. Clark, Bob Anders, Frank Gilliam

Neuroscience Faculty Publications

Objective: For extended-release drugs with multi-compartment kinetics, such as topiramate, effective half-life (t_1/2eff) may be a more clinically relevant parameter than elimination half-life (t_1/2z). Using topiramate as a real-life example, the objective was to compare these half-life values for immediate- and extended-release topiramate (TPM-IR and USL255, respectively) to understand how drug pharmacokinetics may impact drug dosing recommendations.

Methods: The t_1/2z and t_1/2eff for USL255 and TPM-IR were compared using data from a phase I study (N = 36) of 200 mg USL255 administered once daily (QD) or TPM-IR twice daily (BID); effect of sampling duration …