Chemicals and Drugs Commons^™

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

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 …

Addressing Antibiotic Resistance From Farm-Raised Fish Imported To The United States, Nicholas Ali

Bard Center for Environmental Policy

Misuse of medically important antibiotics in animal production threatens the effectiveness of drugs that are vital in combating disease and infections. Recently, the FDA implemented regulations to limit the use of and access to veterinary drugs. However, these regulations only affect domestic production operations. Because over 90% of seafood consumed in the U.S. is imported from countries with different regulatory standards and because the U.S. has an import inspection rate of less than 1%, antibiotic resistance stemming from imported aquaculture is still a risk that is not sufficiently accounted for. This research investigates how the U.S. has reacted to the …

Exploration Of Bioactive Compounds Of Ginger As A Folk Remedy For Migraines, Nathan Vorbes Aleger

Honors Undergraduate Theses

Ginger (Zingiber Officinale) has been used in Asia for centuries to treat various ailments. Ginger has been reported to alleviate migraine pain via four bioactive compounds that can reduce nitric oxide synthase (NOS) resulting in the inhibition of nitric oxide (NO). The inhibition of nitric oxide results in the vasoconstriction of the intracranial blood vessels alleviating migraine pain. It is hypothesized that ginger has structural similarities to vasoconstrictor drugs causing similar receptor interactions. A review of the bioactive compounds in ginger and popular vasoconstrictor drugs was done to determine structural similarities. The results of this study show that …

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

Physician Assistant Scholarly Project Posters

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

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

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

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

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

The Association Between Antipsychotic Medication And Weight Gain, Brian Steen

Physician Assistant Scholarly Project Posters

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

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

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

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

Physician Assistant Scholarly Project Posters

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

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

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

United States Food and Drug Administration: Publications

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

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

Physician Assistant Scholarly Project Posters

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

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

Epidemiology Faculty Publications

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