Open Access. Powered by Scholars. Published by Universities.®
Pharmacy and Pharmaceutical Sciences Commons™
Open Access. Powered by Scholars. Published by Universities.®
- Institution
-
- JSS Academy of Higher Education and Research (86)
- University of Nebraska - Lincoln (65)
- Chapman University (60)
- University of Kentucky (42)
- Ohio Northern University (41)
-
- Technological University Dublin (34)
- University Press of Morocco (25)
- Wayne State University (21)
- Loma Linda University (17)
- Aga Khan University (13)
- Population Council (13)
- Harding University (10)
- Purdue University (10)
- Advocate Health - Midwest (9)
- Nova Southeastern University (9)
- Thomas Jefferson University (9)
- University of Mississippi (9)
- Virginia Commonwealth University (9)
- Walden University (9)
- West Virginia University (9)
- Butler University (8)
- Roseman University of Health Sciences (8)
- Universitas Indonesia (8)
- HCA Healthcare (7)
- Liberty University (7)
- The Texas Medical Center Library (7)
- University of Nebraska Medical Center (7)
- University of Nevada, Las Vegas (7)
- Valparaiso University (7)
- Old Dominion University (6)
- Keyword
-
- COVID-19 (25)
- Pharmacy (21)
- Commencement (17)
- Graduation Program (17)
- LLU (17)
-
- Humans (16)
- Public health (14)
- English (13)
- Vaccines (13)
- Pharmacists (12)
- Opioid (10)
- Opioids (10)
- Patient safety (9)
- SARS-CoV-2 (9)
- Buprenorphine (8)
- Depression (8)
- Female (8)
- HIV (8)
- Medication adherence (8)
- Nutrition (8)
- Obesity (8)
- Radiology (8)
- Screening (8)
- United States (8)
- Diabetes (7)
- Diet (7)
- Health (7)
- Immunization (7)
- Male (7)
- Medication (7)
- Publication Year
- Publication
-
- United States Food and Drug Administration: Publications (61)
- Digital Journal of Clinical Medicine (56)
- Pharmacy Faculty Articles and Research (51)
- Pharmacy and Wellness Review (33)
- SURE Journal: Science Undergraduate Research Experience Journal (32)
-
- Radiology Teaching Files (29)
- Health Sciences (25)
- Commencement Programs (17)
- Department of Pharmacy Practice (14)
- Honors Theses (13)
- Faculty Research and Publications (10)
- Journal of Patient-Centered Research and Reviews (9)
- Walden Dissertations and Doctoral Studies (9)
- Annual Research Symposium (8)
- Theses and Dissertations (8)
- HCA Healthcare Journal of Medicine (7)
- Pharmacy Practice and Science Faculty Publications (7)
- Purdue Journal of Service-Learning and International Engagement (7)
- Reproductive Health (7)
- Theses and Dissertations--Pharmacy (7)
- Graduate Theses, Dissertations, and Problem Reports (ETD) (6)
- Jurnal Ekonomi Kesehatan Indonesia (6)
- Pharmaceutical Sciences Faculty Publications (6)
- Senior Honors Theses (6)
- Pick Me Up Newsletter (5)
- Rowan-Virtua Research Day (5)
- Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.) (5)
- Wayne State University Associated BioMed Central Scholarship (5)
- College of Pharmacy Faculty Papers (4)
- Doctor of Nursing Practice (DNP) Scholarly Projects - Archive (4)
- Publication Type
- File Type
Articles 571 - 600 of 751
Full-Text Articles in Pharmacy and Pharmaceutical Sciences
Student Pharmacists Provide Tobacco Use Prevention Education To Elementary School Children: A Pilot Experience, Jared L. Ostroff, Marissa L. Wolff, Christina Andros, Eric C. Nemec
Student Pharmacists Provide Tobacco Use Prevention Education To Elementary School Children: A Pilot Experience, Jared L. Ostroff, Marissa L. Wolff, Christina Andros, Eric C. Nemec
Physician Associate Studies Faculty Publications
Background and purpose: The purpose of this article is to describe a service learning experience involving tobacco prevention education and to measure the education's effect on the learners' knowledge of tobacco products.
Educational activity and setting: Student pharmacists planned and presented a 40-min tobacco prevention education program using the Tar Wars curriculum to fourth and fifth grade students at three suburban elementary schools in Western Massachusetts. Mean scores on a five-question assessment given to school age children before and after the presentation were compared. A total of 206 elementary school students in ten classrooms participated.
Findings: The average survey score …
Strategies To Improve Control Of Blood A1c In Diabetics, Jennifer Aronson, Leanne Bellino, Elizabeth Eisenhardt, Diane Bryant, Haley Pelletier, Internal Medicine Team, Adult Outpatient Clinic
Strategies To Improve Control Of Blood A1c In Diabetics, Jennifer Aronson, Leanne Bellino, Elizabeth Eisenhardt, Diane Bryant, Haley Pelletier, Internal Medicine Team, Adult Outpatient Clinic
MaineHealth Maine Medical Center
A1c monitoring is an important aspect of controlling the health of a diabetic patient. An adult internal medicine clinic noted that the percentage of their diabetic patients who had an A1c higher than 9 or no reading within the past year exceeded the national average. As a result, operational excellence methods were implemented with the overall goal to reduce their percentage to 18% or less.
A root cause analysis identified several deficiencies to includelack of essential equipment, variations in
staff education and the absence of daily reminders.
Post KPI implementations, an overall decrease in the percentage of patients with poorly …
Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman
Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman
MaineHealth 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 …
Pharmaceutical Federalism, Patricia J. Zettler
Pharmaceutical Federalism, Patricia J. Zettler
Faculty Publications By Year
There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …
Prevalence And Predictors Of Herbal Medicine Use Among Adults In The United States, Mohamed Rashrash, Jon C. Schommer, Lawrence M. Brown
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 …
Commencement Program 2017, Loma Linda University
Commencement Program 2017, Loma Linda University
Commencement Programs
CONTENTS
1 | Message from the President
3 | 2017 Events of Commencement
5 | The Academic Procession
7 | Significance of Academic Regalia
9 | The Good Samaritan
10 | University History Highlights
12 | Loma Linda University Song - "Healing Love"
13 | The University Honorees
26 | The Programs, The School Honorees, and The Speakers
- School of Medicine, 27
- School of Pharmacy, 52
- School of Dentistry, 64
- School of Allied Health Professions - Allied Health Studies, Cardiopulmonary Sciences, Clinical Laboratory Science, Communication Sciences and Disorders, Health Informatics and Information Management, Nutrition and Dietetics, Physician Assistant Sciences, Radiation …
Immune Checkpoint Inhibition And The Prevalence Of Autoimmune Disorders Among Patients With Lung And Renal Cancer, Sherif M. El-Refai
Immune Checkpoint Inhibition And The Prevalence Of Autoimmune Disorders Among Patients With Lung And Renal Cancer, Sherif M. El-Refai
Pharmaceutical Sciences Faculty Publications
PURPOSE: Immune checkpoint inhibition reactivates the immune response against cancer cells in multiple tissue types and has been shown to induce durable responses. However, for patients with autoimmune disorders, their conditions can worsen with this reactivation. We sought to identify, among patients with lung and renal cancer, how many harbor a comorbid autoimmune condition and may be at risk of worsening their condition while on immune checkpoint inhibitors such as nivolumab and pembrolizumab.
METHODS: An administrative health care claims database, Truven MarketScan, was used to identify patients diagnosed with lung and renal cancer from 2010 to 2013. We assessed patients …
Optimizing Medication Appropriateness In Older Adults: A Randomized Clinical Interventional Trial To Decrease Anticholinergic Burden, Daniela C. Moga, Erin L. Abner, Dorinda N. Rigsby, Lynne Eckmann, Mark Huffmyer, Richard R. Murphy, Beth B. Coy, Gregory A. Jicha
Optimizing Medication Appropriateness In Older Adults: A Randomized Clinical Interventional Trial To Decrease Anticholinergic Burden, Daniela C. Moga, Erin L. Abner, Dorinda N. Rigsby, Lynne Eckmann, Mark Huffmyer, Richard R. Murphy, Beth B. Coy, Gregory A. Jicha
Pharmacy Practice and Science Faculty Publications
Background
The complexity of medication therapy in older adults with multiple comorbidities often leads to inappropriate prescribing. Drugs with anticholinergic properties are of particular interest because many are not recognized for this property; their use may lead to increased anticholinergic burden resulting in significant health risks, as well as negatively impacting cognition. Medication therapy management (MTM) interventions showed promise in addressing inappropriate medication use, but the effectiveness of targeted multidisciplinary team interventions addressing anticholinergic medications in older populations is yet to be determined.
Methods
We conducted an 8-week, parallel-arm, randomized trial to evaluate whether a targeted patient-centered pharmacist–physician team MTM …
Activity Of Distinct Growth Factor Receptor Network Components In Breast Tumors Uncovers Two Biologically Relevant Subtypes, Moom Roosan, Shelley M. Macneil, David F. Jenkins, Gajendra Shrestha, Sydney R. Wyatt, Jasmine A. Mcquerry, Stephen R. Piccolo, Laura M. Heiser, Joe W. Gray, W. Evan Johnson, Andrea H. Bild
Activity Of Distinct Growth Factor Receptor Network Components In Breast Tumors Uncovers Two Biologically Relevant Subtypes, Moom Roosan, Shelley M. Macneil, David F. Jenkins, Gajendra Shrestha, Sydney R. Wyatt, Jasmine A. Mcquerry, Stephen R. Piccolo, Laura M. Heiser, Joe W. Gray, W. Evan Johnson, Andrea H. Bild
Pharmacy Faculty Articles and Research
Background
The growth factor receptor network (GFRN) plays a significant role in driving key oncogenic processes. However, assessment of global GFRN activity is challenging due to complex crosstalk among GFRN components, or pathways, and the inability to study complex signaling networks in patient tumors. Here, pathway-specific genomic signatures were used to interrogate GFRN activity in breast tumors and the consequent phenotypic impact of GRFN activity patterns.
Methods
Novel pathway signatures were generated in human primary mammary epithelial cells by overexpressing key genes from GFRN pathways (HER2, IGF1R, AKT1, EGFR, KRAS (G12V), RAF1, BAD). The pathway analysis toolkit Adaptive Signature Selection …
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
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
United States Food and Drug Administration: Publications
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 …
Outcomes After Diagnosis Of Mild Cognitive Impairment In A Large Autopsy Series, Erin L. Abner, Richard J. Kryscio, Frederick A. Schmitt, David W. Fardo, Daniela C. Moga, Eseosa T. Ighodaro, Gregory A. Jicha, Lei Yu, Hiroko H. Dodge, Chengjie Xiong, Randall L. Woltjer, Julie A. Schneider, Nigel J. Cairns, David A. Bennett, Peter T. Nelson
Outcomes After Diagnosis Of Mild Cognitive Impairment In A Large Autopsy Series, Erin L. Abner, Richard J. Kryscio, Frederick A. Schmitt, David W. Fardo, Daniela C. Moga, Eseosa T. Ighodaro, Gregory A. Jicha, Lei Yu, Hiroko H. Dodge, Chengjie Xiong, Randall L. Woltjer, Julie A. Schneider, Nigel J. Cairns, David A. Bennett, Peter T. Nelson
Epidemiology and Environmental Health Faculty Publications
OBJECTIVE: To determine clinical and neuropathological outcomes following a clinical diagnosis of mild cognitive impairment (MCI).
METHODS: Data were drawn from a large autopsy series (N = 1,337) of individuals followed longitudinally from normal or MCI status to death, derived from 4 Alzheimer Disease (AD) Centers in the United States.
RESULTS: Mean follow‐up was 7.9 years. Of the 874 individuals ever diagnosed with MCI, final clinical diagnoses were varied: 39.2% died with an MCI diagnosis, 46.8% with a dementia diagnosis, and 13.9% with a diagnosis of intact cognition. The latter group had pathological features resembling those with a final clinical …
Biokinetics Of Nanomaterials: The Role Of Biopersistence, Peter Laux, Christian Riebeling, Andy M. Booth, Joseph D. Brain, Josephine Brunner, Cristina Cerrillo, Otto Creutzenberg, Irina Estrela-Lopis, Thomas Gebel, Gunnar Johanson, Harald Jungnickel, Heiko Kock, Jutta Tentschert, Ahmed Tlili, Andreas Schäffer, Adriënne J. A. M. Sips, Robert A. Yokel, Andreas Luch
Biokinetics Of Nanomaterials: The Role Of Biopersistence, Peter Laux, Christian Riebeling, Andy M. Booth, Joseph D. Brain, Josephine Brunner, Cristina Cerrillo, Otto Creutzenberg, Irina Estrela-Lopis, Thomas Gebel, Gunnar Johanson, Harald Jungnickel, Heiko Kock, Jutta Tentschert, Ahmed Tlili, Andreas Schäffer, Adriënne J. A. M. Sips, Robert A. Yokel, Andreas Luch
Pharmaceutical Sciences Faculty Publications
Nanotechnology risk management strategies and environmental regulations continue to rely on hazard and exposure assessment protocols developed for bulk materials, including larger size particles, while commercial application of nanomaterials (NMs) increases. In order to support and corroborate risk assessment of NMs for workers, consumers, and the environment it is crucial to establish the impact of biopersistence of NMs at realistic doses. In the future, such data will allow a more refined categorization of NMs. Despite many experiments on NM characterization and numerous in vitro and in vivo studies, several questions remain unanswered including the influence of biopersistence on the toxicity …
Buprenorphine Physician Supply: Relationship With State-Level Prescription Opioid Mortality, Hannah K. Knudsen, Jennifer R. Havens, Michelle R. Lofwall, Jamie L. Studts, Sharon L. Walsh
Buprenorphine Physician Supply: Relationship With State-Level Prescription Opioid Mortality, Hannah K. Knudsen, Jennifer R. Havens, Michelle R. Lofwall, Jamie L. Studts, Sharon L. Walsh
Behavioral Science Faculty Publications
Background: Buprenorphine is an effective treatment for opioid use disorder but the supply of buprenorphine physicians is currently inadequate to address the nation’s prescription opioid crisis. Perception of need due to rising opioid overdose rates is one possible reason for physicians to adopt buprenorphine. This study examined associations between rates of growth in buprenorphine physicians and prescription opioid overdose mortality rates in US states.
Methods: The total buprenorphine physician supply and number of physicians approved to treat 100 patients (per 100,000 population) were measured from June 2013 to January 2016. States were divided into two groups: those with rates of …
Impact Of Health Policy Changes On Emergency Medicine In Maryland Stratified By Socioeconomic Status, Laura Pimentel, David Anderson, Bruce Golden, Edward Wasil, Fermin Barreuto, Jon M. Hirshon
Impact Of Health Policy Changes On Emergency Medicine In Maryland Stratified By Socioeconomic Status, Laura Pimentel, David Anderson, Bruce Golden, Edward Wasil, Fermin Barreuto, Jon M. Hirshon
Publications and Research
Introduction: On January 1, 2014, the financing and delivery of healthcare in the state of Maryland (MD) profoundly changed. The insurance provisions of the Patient Protection and Affordable Care Act (ACA) began implementation and a major revision of MD’s Medicare waiver ushered in a Global Budget Revenue (GBR) structure for hospital reimbursement. Our objective was to analyze the impact of these policy changes on emergency department (ED) utilization, hospitalization practices, insurance profiles, and professional revenue. We stratified our analysis by the socioeconomic status (SES) of the ED patient population.
Methods: We collected monthly mean data including patient volume, hospitalization percentages, …
Utilizing Three Years Of Epidemiological Data From Medical Missions In Cambodia To Shape The Mobile Medical Clinic Formulary, Jeany Kim Jun, Junia S. Koo, Amy Y. Kang, Deborah B. Chien, Albert Shim, Dale Knutson, Eda M. Kim
Utilizing Three Years Of Epidemiological Data From Medical Missions In Cambodia To Shape The Mobile Medical Clinic Formulary, Jeany Kim Jun, Junia S. Koo, Amy Y. Kang, Deborah B. Chien, Albert Shim, Dale Knutson, Eda M. Kim
Pharmacy Faculty Articles and Research
Objective: The purpose of this project was to gather epidemiological data on common diseases and medications dispensed during medical mission teams to Cambodia to shape the mobile medical clinic formulary.
Methods: Data for patients seen during week-long, mobile, medical clinics was collected in Cambodia during Septembers 2012 to 2014. Patient’s gender, age, weight, blood pressure, glucose, pertinent laboratory values, diagnoses, and medications dispensed were collected. Blood pressure and glucose were measured in patients 18 years and above. Data collected onto paper intake forms were transferred onto spreadsheets without patient identifying information and analyzed for aggregate means, common diseases, and most …
Recurrent Pneumonia Among Japanese Adults: Disease Burden And Risk Factors, Tomoko Ishifuji, Eiichiro Sando, Norihiro Kaneko, Motoi Suzuki, Paul E. Kilgore, Koya Ariyoshi, Konosuke Morimoto, Naoto Hosokawa, Makito Yaegashi, Masahiro Aoshima, Adult Pneumonia Study Group - Japan (Apsg-J)
Recurrent Pneumonia Among Japanese Adults: Disease Burden And Risk Factors, Tomoko Ishifuji, Eiichiro Sando, Norihiro Kaneko, Motoi Suzuki, Paul E. Kilgore, Koya Ariyoshi, Konosuke Morimoto, Naoto Hosokawa, Makito Yaegashi, Masahiro Aoshima, Adult Pneumonia Study Group - Japan (Apsg-J)
Department of Pharmacy Practice
Background: In Japan and other societies with rapidly aging populations, recurrent pneumonia (RP) is a major clinical problem yet only limited information exists regarding the burden of this disease.
Methods: A prospective study of adult pneumonia was conducted to investigate the incidence of RP and potential risk factors. From February 1, 2012 to January 31, 2013, patients aged ≥ 15 years who were diagnosed with pneumonia were prospectively enrolled in a representative community hospital located in central Japan. Patients were followed for one-year to evaluate the recurrence of pneumonia and characteristics associated with RP. Cox proportional hazards models were constructed …
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
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
United States Food and Drug Administration: Publications
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, …
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
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
United States Food and Drug Administration: Publications
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 …
Detection Of Allergen Markers In Food: Analytical Methods, Girdhari M. Sharma, Sefat E. Khuda, Christine H. Parker, Anne C. Eischeid, Marion Pereira
Detection Of Allergen Markers In Food: Analytical Methods, Girdhari M. Sharma, Sefat E. Khuda, Christine H. Parker, Anne C. Eischeid, Marion Pereira
United States Food and Drug Administration: Publications
Food allergens are proteins that are well tolerated by most, but can cause severe reactions in sensitive individuals. Since there is no cure for food allergy, strict adherence to an allergen-free diet is the only safe choice currently available for allergic consumers. Accurate food labeling can help consumers avoid foods containing an allergenic ingredient. Regulatory agencies have mandated the labeling of major food allergens on packaged foods to help with safe food choices. However, the inadvertent presence of an allergen in food due to cross-contact and labeling error can jeopardize consumer health. Analytical methods are developed for allergen detection and …
Current Analytical Techniques For Food Lipids, Cynthia T. Srigley, Magdi M. Mossoba
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
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
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
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
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
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
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
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 (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 …
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
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
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
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 …