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Public Health

2017

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Full-Text Articles in Chemicals and Drugs

Antibiotic Resistance In Escherichia Coli Iron Transport Mutants, Madeline Brandt Dec 2017

Antibiotic Resistance In Escherichia Coli Iron Transport Mutants, Madeline Brandt

Honors Projects

Studies previously completed on Escherichia coli mutants suggested the possibility of iron uptake as an influence on the antibiotic resistance seen in different strains. The research focused on the TonB energy transduction system and its contributions to efflux-mediated antibiotic resistance. To test the hypothesis that iron uptake has an influence on antibiotic resistance in Escherichia coli, the sensitivity to a variety of antibiotics was evaluated in strains of E. coli lacking genes that relate to the uptake of iron or the efflux system that is necessary for the uptake of iron. To test the efflux systems TolC and TonB …


Combinational Sirna Delivery Using Hyaluronic Acid Modified Amphiphilic Polyplexes Against Cell Cycle And Phosphatase Proteins To Inhibit Growth And Migration Of Triple-Negative Breast Cancer Cells, Manoj B. Parmar, Daniel Nisakar Meenakshi Sundaram, Remant Bahadur Kc, Robert Maranchuk, Hamidreza Montazeri Aliabadi, Judith C. Hugh, Raimar Löbenberg, Hasan Uludağ Nov 2017

Combinational Sirna Delivery Using Hyaluronic Acid Modified Amphiphilic Polyplexes Against Cell Cycle And Phosphatase Proteins To Inhibit Growth And Migration Of Triple-Negative Breast Cancer Cells, Manoj B. Parmar, Daniel Nisakar Meenakshi Sundaram, Remant Bahadur Kc, Robert Maranchuk, Hamidreza Montazeri Aliabadi, Judith C. Hugh, Raimar Löbenberg, Hasan Uludağ

Pharmacy Faculty Articles and Research

Triple-negative breast cancer is an aggressive form of breast cancer with few therapeutic options if it recurs after adjuvant chemotherapy. RNA interference could be an alternative therapy for metastatic breast cancer, where small interfering RNA (siRNA) can silence the expression of aberrant genes critical for growth and migration of malignant cells. Here, we formulated a siRNA delivery system using lipid-substituted polyethylenimine (PEI) and hyaluronic acid (HA), and characterized the size, ζ-potential and cellular uptake of the nanoparticulate delivery system. Higher cellular uptake of siRNA by the tailored PEI/HA formulation suggested better interaction of complexes with breast cancer cells due to …


Relationship Between Self-Efficacy And Patient Knowledge On Adherence To Oral Contraceptives Using The Morisky Medication Adherence Scale (Mmas-8), Daniel M. Tomaszewski, Benjamin D. Aronson, Margarette Kading, Donald Morisky Sep 2017

Relationship Between Self-Efficacy And Patient Knowledge On Adherence To Oral Contraceptives Using The Morisky Medication Adherence Scale (Mmas-8), Daniel M. Tomaszewski, Benjamin D. Aronson, Margarette Kading, Donald Morisky

Pharmacy Faculty Articles and Research

Background: Preconception care, including family planning, is a vital component of healthcare for women of reproductive age. An average female spends the majority of her reproductive life trying to prevent a pregnancy. In order to prevent unintended pregnancy, women often rely on the use of hormonal contraceptives. In the United States, the majority of hormonal contraceptive users are prescribed oral contraceptive pills (OCPs). Reduced adherence to OCPs decreases their ability to prevent pregnancy. The study aimed to measure OCP adherence among female college students, and explore the relationship between OCP adherence, knowledge, and self-efficacy.

Methods: This cross-sectional study …


Analyzing The Effectiviness Of A Prescription Drug Monitoring Program Targeting At-Risk Opioid Abuse Patients, Treadway Childs Aug 2017

Analyzing The Effectiviness Of A Prescription Drug Monitoring Program Targeting At-Risk Opioid Abuse Patients, Treadway Childs

Public Administration ETDs

The effectiveness of a prescription drug monitoring program in coordination with a prescription opioid recidivism program was examined at a semi-rural community hospital. Patients were identified by a multi-disciplinary committee to be at-risk for opioid misuse or abuse, and were denied prescription opioids. Patients were considered eligible for the program if they had over 12 emergency department visits in the previous 12 months, or 6 visits in the previous 6 months, depending on how long the hospital had records on a patient. Patients who were placed in the prescription opioid recidivism program could not receive opioids at this hospital. The …


Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman Aug 2017

Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman

Maine Medical Center

There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.

After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …


Abnormal Dendritic Maturation Of Developing Cortical Neurons Exposed To Corticotropin Releasing Hormone (Crh): Insights Into Effects Of Prenatal Adversity?, Megan M. Curran, Curt A. Sandman, Elyssia Poggi Davis, Laura M. Glynn, Tallie Z. Baram Jun 2017

Abnormal Dendritic Maturation Of Developing Cortical Neurons Exposed To Corticotropin Releasing Hormone (Crh): Insights Into Effects Of Prenatal Adversity?, Megan M. Curran, Curt A. Sandman, Elyssia Poggi Davis, Laura M. Glynn, Tallie Z. Baram

Psychology Faculty Articles and Research

Corticotropin releasing hormone (CRH) produced by the hypothalamus initiates the hypothalamic- pituitary-adrenal (HPA) axis, which regulates the body's stress response. CRH levels typically are undetectable in human plasma, but during pregnancy the primate placenta synthesizes and releases large amounts of CRH into both maternal and fetal circulations. Notably, placental CRH synthesis increases in response to maternal stress signals. There is evidence that human fetal exposure to high concentrations of placental CRH is associated with behavioral consequences during infancy and into childhood, however the direct effects on of the peptide on the human brain are unknown. In this study, we used …


Prevalence And Predictors Of Herbal Medicine Use Among Adults In The United States, Mohamed Rashrash, Jon C. Schommer, Lawrence M. Brown Jun 2017

Prevalence And Predictors Of Herbal Medicine Use Among Adults In The United States, Mohamed Rashrash, Jon C. Schommer, Lawrence M. Brown

Pharmacy Faculty Articles and Research

Objective: To describe the prevalence of herbal medicine use among US adults and to assess factors associated with and predictors of herbal use. Design: The data for herbal products use were collected from the 2015 National Consumer Survey on the Medication Experience and Pharmacists’ Roles. Chi-square test was used to analyz factors associated with herbal use, and predictors of herbal use were assessed with logistic regression analysis. Results: Factors associated with herbal supplement use include age older than 70, having a higher than high school education, using prescription medications or over-thecounter (OTC) medications, and using a mail-order …


A Descriptive Study Of The Elderly In California Substance Abuse Treatment Programs, David Berenschot Jun 2017

A Descriptive Study Of The Elderly In California Substance Abuse Treatment Programs, David Berenschot

Electronic Theses, Projects, and Dissertations

As gerontologists may know, there are a great deal of studies and a variety of academic literature on the misuse of alcohol and prescription medication amongst the elderly population. While there is a plethora of information on alcohol and prescription misuse, there is little reported data about the prevalence of other substance misuse experienced by this population. This study aims to help to fill that gap in the data by using quantitative methods to describe the scope of substance abuse of individuals 55-years or older. This study utilizes data from the Treatment Data Set Admission (TEDS-A). The TEDS-A is a …


Determining The Knowledge, Attitudes And Beliefs Of Healthcare Providers In Treating Non-Specific Acute And Chronic Back Pain, Stacey L. Kale May 2017

Determining The Knowledge, Attitudes And Beliefs Of Healthcare Providers In Treating Non-Specific Acute And Chronic Back Pain, Stacey L. Kale

Doctor of Nursing Practice Scholarly Project

An Abstract of the Scholarly Project by

Stacey Kale

Managing back pain has become a public health and clinical challenge (Krein et al., 2016). Incidence of back pain related complaints requiring treatment in the US is estimated at 11.2% of the adult population (Dowell, Haegerich, & Chou, 2016). New research suggests that it is the most common pain problem (Pauline, 2016). It is the third most expensive health disorder and is exceeded only by cancer and heart disease. Many health care providers lack formal pain management education and training thus leaving them at risk for failing to properly manage patients …


Addressing Childhood Lead Poisoning Through Gis: A Proactive Approach In Scott County, Iowa, Tanner Osing May 2017

Addressing Childhood Lead Poisoning Through Gis: A Proactive Approach In Scott County, Iowa, Tanner Osing

2016-2017: Scott County, Iowa and the Scott County Health Department

In June 2016, Scott County Health Department (SHCD) officially partnered with the Upper Mississippi Center (UMC) at Augustana College as part of the Sustainable Working Landscapes Initiative (SWLI). The initiative’s main goal is to address childhood lead poisoning in Scott County, Iowa. While the health department has ongoing efforts to address the problem, there are still approximately 50 children testing positive for lead poisoning every year (Tibbets, 2016). Currently, as part of the Childhood Lead Poisoning Prevention and Control Program, the health department offers case management services for children poisoned under the age of six, follow-up inspections for residences, and …


Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo Apr 2017

Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo

Food and Drug Administration Papers

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-D-aspartic acid receptors. Adverse drug–drug interaction effects between ketamine and CsA have been reported in mammals and humans. However, the mechanism of such drug–drug interaction is unclear. We have previously reported adverse effects of combination drugs, such as verapamil/ketamine and shown the mechanism through intervention by other drugs in zebrafish embryos. Here, we show that ketamine and CsA in combination produce developmental toxicity even leading to lethality in zebrafish larvae …


Children’S Exposure To Environmental Toxins: Socioeconomic Factors And Subsequent Effects On Mental Health And Function, Dorothy L. Mcleod Apr 2017

Children’S Exposure To Environmental Toxins: Socioeconomic Factors And Subsequent Effects On Mental Health And Function, Dorothy L. Mcleod

Center for the Human Rights of Children

The physical environment in which children live, including the air they breathe and the water they drink, has a profound influence on their development. While children need many chemicals and nutrients to physically grow and develop normally, others, such as those deemed environmental toxins (e.g. pesticides, lead, mercury, and illicit substances) act instead as a threat to healthy development. These chemicals may have highly toxic effects, and while they are a threat to all individuals, they affect infants and children most severely. In order to provide an introduction to the issue of toxin exposure and mental health outcomes, to highlight …


Clinical Impact Of An Antibiotic Stewardship Program At A Children's Hospital., Brian R. Lee, Jennifer Goldman, Diana Yu, Angela Myers, Leslie M. Stach, Erin Hedican, Mary Anne Jackson, Jason G. Newland Mar 2017

Clinical Impact Of An Antibiotic Stewardship Program At A Children's Hospital., Brian R. Lee, Jennifer Goldman, Diana Yu, Angela Myers, Leslie M. Stach, Erin Hedican, Mary Anne Jackson, Jason G. Newland

Manuscripts, Articles, Book Chapters and Other Papers

INTRODUCTION: Antibiotic stewardship programs (ASP) improve appropriate antibiotic use. Data are limited on the clinical benefit of ASPs in children's hospitals. This study's objective was to determine the impact of an ASP on length of stay (LOS) and readmission rate among patients admitted to children's hospitals.

METHODS: Data from a prospective-audit-with-feedback ASP were used to examine the ASP review characteristics, including antibiotic(s) prescribed, clinical indication, recommendations made by the ASP, and agreement with recommendations. Propensity score analysis was utilized to determine the impact of the ASP on LOS and 30-day readmission based on whether the patient received an ASP recommendation …


Black Hawk County’S Approach To Lead Poisoning, Ashley Comeau, Taylor Campbell, Nathan Ambrose, Travis Pulse Jan 2017

Black Hawk County’S Approach To Lead Poisoning, Ashley Comeau, Taylor Campbell, Nathan Ambrose, Travis Pulse

2016-2017: Scott County, Iowa and the Scott County Health Department

Scott County, IA is facing a community lead poisoning problem, much like other counties in the state. One of these are Black Hawk County, northwest of Scott. Black Hawk County approached the lead poisoning problem by partnering with organizations including the University of Northern Iowa, the Iowa Poison Control Center, and a multitude of medical groups. Funding, procedures for action, and education were also factors in assessing the lead problem. Black Hawk County’s number of lead poisonings decreased after approaching the problem, while Scott County’s problem worsened. By using similar methods, we hope that Scott County's lead problem will also …


Lead Poisoning In Linn County & Cedar Rapids, Ia, Sydney Fedor, Lexys Magadan, Shannon Okland, Morghan Smith, Anna Willems Jan 2017

Lead Poisoning In Linn County & Cedar Rapids, Ia, Sydney Fedor, Lexys Magadan, Shannon Okland, Morghan Smith, Anna Willems

2016-2017: Scott County, Iowa and the Scott County Health Department

No abstract provided.


Risk Of Gastrointestinal Bleeding Among Dabigatran Users – A Self Controlled Case Series Analysis, Wenze Tang, Hsien-Yen Chang, Meijia Zhou, Sonal Singh Jan 2017

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 …


Does Medication Safety And Diversion Education Improve Medication Securement Practices In Scu Compared To Current Practice?, Natasha R. Stankiewicz Jan 2017

Does Medication Safety And Diversion Education Improve Medication Securement Practices In Scu Compared To Current Practice?, Natasha R. Stankiewicz

Interprofessional Research and Innovations Council

Does medication safety and diversion education improve medication securement practices in SCU compared to current practice?

Abstract

Natasha R. Stankiewicz, MS, RN, NE-BC, CCRN-CMC

This safety quality improvement project began as newly hired SCU2 team members saw an opportunity to improve our medication safety practices and culture. The convenience of having certain medications directly available at bedside was priority. There was a lack of awareness and interest in securing medications within the department. However, the risk to our patients, families, visitors and colleagues when medications are left out, available and unsecured was apparent to new staff and others. Prior to …


Assessment Of The Use Of Overdose Education And Naloxone Distribution By Maine Buprenorphine/Naloxone Prescribers, Stephen Kirsch Jan 2017

Assessment Of The Use Of Overdose Education And Naloxone Distribution By Maine Buprenorphine/Naloxone Prescribers, Stephen Kirsch

Muskie School Capstones and Dissertations

Background: Overdose deaths, specifically related to opioids, have been identified as a public health problem both nationally and in the state of Maine. Overdose Education and Naloxone Distribution (OEND) is an innovative model of patient education that has been shown to be effective in increasing knowledge of overdose risk and has the potential to help reduce opiate related overdose deaths.

Methods: A 28-item web-based survey examining clinician attitudes, OEND practices and characteristics was distributed to 196 Maine based physicians with a Drug Enforcement Agency waiver to prescribe burprenorphine/naloxone. Facilitators and barriers to the provision of OEND were also assessed. Surveys …


Food Safety Traceability, Yimin Wei, Boli Guo, Hongyan Liu, Shuai Wei, Jianrong Zhang Jan 2017

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

Food and Drug Administration Papers

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 Jan 2017

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

Food and Drug Administration Papers

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 …


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 Jan 2017

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

Food and Drug Administration Papers

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).


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 Jan 2017

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

Food and Drug Administration Papers

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 Jan 2017

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

Food and Drug Administration Papers

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 …


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 Jan 2017

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

Food and Drug Administration Papers

The presence and survival of Salmonella in low water activity (aw) 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 …


The Mechanism Of Cirp In Inhibition Of Keratinocytes Growth Arrest And Apoptosis Following Low Dose Uvb Radiation, Yi Liao, Jianguo Feng, Yi Zhang, Liling Tang, Shiyong Wu Jan 2017

The Mechanism Of Cirp In Inhibition Of Keratinocytes Growth Arrest And Apoptosis Following Low Dose Uvb Radiation, Yi Liao, Jianguo Feng, Yi Zhang, Liling Tang, Shiyong Wu

Food and Drug Administration Papers

UV induces CIRP expression and subsequent Stat3 activation, but the biological function and mechanism of CIRP and Stat3 in mediating UVB-induced skin carcinogenesis have not been fully elucidated. In this study, we demonstrate that CIRP is elevated in all tested melanoma and non-melanoma skin cancer cell lines; and the expression of CIRP is upregulated in keratinocytes after being irradiated with relatively low dose (<5 mJ/cm2), but not high dose (50 mJ/cm2), UVB acutely and chronically. The increased expression of CIRP, either induced by UVB or through overexpression, leads to resistance of keratinocytes to UVB-induced growth arrest and …


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 Jan 2017

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

Food and Drug Administration Papers

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 …


Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo Jan 2017

Cyclosporine Exacerbates Ketamine Toxicity In Zebrafish: Mechanistic Studies On Drug–Drug Interaction, Bonnie L. Robinson, Melanie Dumas, Syed F. Ali, Merle G. Paule, Qiang Gu, Jyotshna Kanungo

Food and Drug Administration Papers

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-D-aspartic acid receptors. Adverse drug–drug interaction effects between ketamine and CsA have been reported in mammals and humans. However, the mechanism of such drug–drug interaction is unclear. We have previously reported adverse effects of combination drugs, such as verapamil/ketamine and shown the mechanism through intervention by other drugs in zebrafish embryos. Here, we show that ketamine and CsA in combination produce developmental toxicity even leading to lethality in zebrafish larvae when exposure began …


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 Jan 2017

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

Food and Drug Administration Papers

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 …


Variation In Organ-Specific Pik3ca And Kras Mutant Levels In Normal Human Tissues Correlates With Mutation Prevalence In Corresponding Carcinomas, Barbara L. Parsons, Karen L. Mckim, Meagan B. Myers Jan 2017

Variation In Organ-Specific Pik3ca And Kras Mutant Levels In Normal Human Tissues Correlates With Mutation Prevalence In Corresponding Carcinomas, Barbara L. Parsons, Karen L. Mckim, Meagan B. Myers

Food and Drug Administration Papers

Large-scale sequencing efforts have described the mutational complexity of individual cancers and identified mutations prevalent in different cancers. As a complementary approach, allele specific competitive blocker PCR (ACB-PCR) is being used to quantify levels of hotspot cancer driver mutations (CDMs) with high sensitivity, to elucidate the tissue-specific properties of CDMs, their occurrence as tumor cell subpopulations, and their occurrence in normal tissues. Here we report measurements of PIK3CA H1047R mutant fraction (MF) in normal colonic mucosa, normal lung, colonic adenomas, colonic adenocarcinomas, and lung adenocarcinomas. We report PIK3CA E545K MF measurements in those tissues, as well as in normal breast, …


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 Jan 2017

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

Food and Drug Administration Papers

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 …