Pharmaceutical Preparations Commons^™

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).

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 …

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

United States Food and Drug Administration: Publications

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

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

United States Food and Drug Administration: Publications

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

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

United States Food and Drug Administration: Publications

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

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

United States Food and Drug Administration: Publications

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

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

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

United States Food and Drug Administration: Publications

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

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

United States Food and Drug Administration: Publications

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

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

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

United States Food and Drug Administration: Publications

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 …

Monitoring Harm Perceptions Of Smokeless Tobacco Products Among U.S. Adults: Health Information National Trends Survey 2012, 2014, 2015, Shari P. Feirman, Elisabeth A. Donaldson, Mark Parascandola, Kimberly Snyder, Cindy Tworek

United States Food and Drug Administration: Publications

Introduction: Changes to the U.S. smokeless tobacco landscape in recent years include a change to health warnings on packages, the implementation of bans in some stadiums, and the launch of a federal youth pre- vention campaign. It is unclear whether such changes have impacted consumer beliefs about smokeless tobacco. This study examines relative harm perceptions of smokeless tobacco compared to cigarettes among adults and assesses changes in smokeless tobacco harm perceptions over time.

Methods: We analyzed data from three cycles (2012, 2014, 2015) of the Health Information National Trends Survey (HINTS). Using 2015 data, we assessed bivariate associations between smokeless …

Volumetry Of Low-Contrast Liver Lesions With Ct: Investigation Of Estimation Uncertainties In A Phantom Study, Qin Li, Yongguang Liang, Qiao Huang, Min Zong, Benjamin Berman, Marios A. Gavrielides, Lawrence H. Schwartz, Binsheng Zhao, Nicholas Petrick

United States Food and Drug Administration: Publications

Purpose: To evaluate the performance of lesion volumetry in hepatic CT as a function of various imaging acquisition parameters.

Methods: An anthropomorphic abdominal phantom with removable liver inserts was designed for this study. Two liver inserts, each containing 19 synthetic lesions with varying diameter (6–40 mm), shape, contrast (10–65 HU), and both homogenous and mixed-density were designed to have background and lesion CT values corresponding to arterial and portal-venous phase imaging, respectively. The two phantoms were scanned using two commercial CT scanners (GE 750 HD and Siemens Biograph mCT) across a set of imaging protocols (four slice thicknesses, …

Investigation Of Tattoo Pigments By Raman Spectroscopy, Betsy Jean Yakes, Tara Jade Michael, Marianita Perez-Gonzalez, Bhakti Petigara Harp

United States Food and Drug Administration: Publications

As a result of the increase in the practice of tattooing, the US Food and Drug Administration has identified a need for improved analytical methods to detect the pigments and potential impurities in the inks. Raman spectroscopy allows for nondestructive identification of compounds and is commonly used in art, archaeology, and forensics; however, the technique has only limitedly been applied to the identification of tattoo pigments. In this study, approximately 30 inorganic, organometallic, and organic pigmentswere evaluated with Raman spectroscopy by using 532, 633, and 780-nmlasers. Individual optimization of the instrumental parameters was performed for each pigment in order to …

Bacterial Endotoxin Detection In Hyaluronic Acid-Based Medical Devices, Larissa F. Baeva, Srilekha Sarkar Das, Victoria M. Hitchins

United States Food and Drug Administration: Publications

A simple and rapid method has been developed for testing bacterial endotoxin in hyaluronic acid (HA)-based medical devices. High-molecular-weight HA (HMW HA) in solution or HA-based medical devices was digested by the enzyme hyaluronidase to reduce solution viscosity by truncating the long chains of HA and to test for bacterial endotoxin. The bacterial endotoxin level was detected and measured by kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay. The method was applied to two different ophthalmic viscosurgical devices (OVDs) and one dermal filler, and may easily be adapted to use with up to 3% HA solutions and other HA-based medical devices.

Pharmacokinetics And Distribution In Interstitial And Pulmonary Epithelial Lining Fluid Of Danofloxacin In Ruminant And Preruminant Calves, D. A. Mzyk, R. E. Baynes, K. M. Messenger, M. Martinez, G. W. Smith

United States Food and Drug Administration: Publications

The objective of this study was to compare active drug concentrations in the plasma vs. different effector compartments including interstitial fluid (ISF) and pulmonary epithelial lining fluid (PELF) of healthy preruminating (3-week-old) and ruminating (6-month-old) calves. Eight calves in each age group were given a single subcutaneous (s.c.) dose (8 mg/kg) of danofloxacin. Plasma, ISF, and bronchoalveolar lavage (BAL) fluid were collected over 96 h and analyzed by high-pressure liquid chromatography. PELF concentrations were calculated by a urea dilution assay of the BAL fluids. Plasma protein binding was measured using a microcentrifugation system. For most preruminant and ruminant calves, the …

Contraceptive Provision To Adolescent Females Prescribed Teratogenic Medications., Stephani L. Stancil, Melissa K. Miller, Holley Briggs, Daryl Lynch, Kathy Goggin, Gregory Kearns

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND AND OBJECTIVES: Rates of adult women receiving contraceptive provision when simultaneously prescribed a known teratogen are alarmingly low. The prevalence of this behavior among pediatric providers and their adolescent patients is unknown. The objective of this study was to describe pediatric provider behaviors for prescribing teratogens concurrently with counseling, referral, and/or prescribing of contraception (collectively called contraceptive provision) in the adolescent population.

METHODS: A retrospective review was conducted examining visits in 2008-2012 by adolescents aged 14 to 25 years in which a known teratogen (US Food and Drug Administration pregnancy risk category D or X) was prescribed. The electronic …

Scientific And Regulatory Policy Committee (Srpc) Review*: Interpretation And Use Of Cell Proliferation Data In Cancer Risk Assessment, Charles E. Wood, Renee R. Hukkanen, Radhakrisha Sura, David Jacobson-Kram, Thomas Nolte, Marielle Odin, Samuel M. Cohen

United States Food and Drug Administration: Publications

Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardiza- tion of proliferation assays will …

Vaccine-Preventable Diseases In Travelers, Edith Mirzaian, Jeffery A. Goad, Ani Amloian, Fady Makar

Pharmacy Faculty Articles and Research

Travel to the developing world is increasing among those from developed countries, placing them at risk for vaccine preventable and non-vaccine preventable diseases. From 2007-2011, the GeoSentinel Network reported 737 returned travelers with a vaccine preventable disease. While it is essential that clinicians use vaccines when available for a disease of risk, they should also be aware that the vast majority of diseases acquired by travelers are non-vaccine preventable. The vaccine preventable diseases can be divided into routine travel vaccines, special travel vaccines and routine vaccines used for travel. The routine travel vaccines include Hepatitis A and B, typhoid; special …

"Mercy Tape" Unveiled: Provides Better Weight Estimates For Children, Bill Van Kirk

Our Story Continues

Susan Abdel-Rahman, Pharm.D, Clinical Pharmacology and Medical Toxicology, led the Children's Mercy research team that developed the Mercy TAPE, a new device to estimate the weight of pediatric patients ages two months to 16 years.

Accurate weight estimates in resource-restricted settings (lacking the means to weigh a child) are important because they are used to determine appropriate medication dosage, fluid volumes for resuscitation, breathing tube sizes, and more.

Characterization Of Pasteurella Multocida Strains Isolated From Geese, Zsuzsanna Varga, Dmitriy V. Volokhov, Laszlo Stipkovits, Akos Thuma, Boglarka Sellyei, Tibor Magyar

United States Food and Drug Administration: Publications

Phenotypic and genotypic diversity of forty-two Pasteurella multocida isolates from geese were characterized by analysis of their capsular type, Heddleston serotype, biotype, fimbrial gene allele type, comparative outer membrane protein (OMP) electrophoresis patterns, and were analyzed using PCR for the presence of virulence-associated genes (toxA, tbpA, pfhA, hgbA, hgbB, nanH, nanB, fimA, hsf-1, and pmHAS). A sequence comparison of the thdF and rpoB housekeeping genes of twenty representative P. multocida strains from three different OMP groups demonstrated that seventeen strains were closely related phylogenetically to previously published strains of P. multocida subsp. multocida and P. multocida subsp. gallicida, and only …

Retirees And Pharmaceutical Costs: Is There Really A Crisis?, Justine Maiello

Seton Hall University Dissertations and Theses (ETDs)

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Trends. The Politics Of Psychopathology: Ritalin Conspiracy As Paranoia Or As Good Business?, Ibpp Editor

International Bulletin of Political Psychology

This article discusses the intersection of science, pharmaceuticals, and politics in the context of Ritalin and an alleged over-diagnosis of attention deficit disorder (ADD).

What Is The Risk Of Teratogenicity With The Use Of Selective Serotonin Reuptake Inhibitors During Pregnancy?, Michael Z. Wincor, Mary Gutierrez, Ann Nguyen

Pharmacy Faculty Articles and Research

"The lifetime prevalence of major depressive disorder in women is 10 to 25%, with an average age of onset in the mid-20s.1 Over the nine years that the selective serotonin reuptake inhibitors (SSRis) have been available, for many prescribers, they have become first-line agents in the treatment of depression. In addition, sorne of them are also being used in the treatment of obsessive- compulsive disorder and panic disorder. In light of these facts, itis not unlikely that women of childbearing age would be treated with one of the SSRis. In considering the risks of exposing a fetus to an SSRI, …

The Chemistry Of Pesticides, Walter R. Benson

United States Food and Drug Administration: Publications

Introduction

This review is limited to the structures and a few reactions of the pesticides mainly insecticides-that affect mammalian systems and that are the subject of papers by other authors in this monograph. There is no attempt to give a complete review of the chemistry of pesticides. It is intended only to show the breadth and depth of pesticide chemistry through the use of examples. With proper use of the references, and of the papers by Crosby, Freed and Montgomery, and Owens in this monograph, the reader will be able to find information for other chemicals.

Nomenclature

Pesticides or economic …

Quantitative Calculation Of Gas Chromatographic Peaks In Pesticide Residue Analyses, Jean A. Gaul

United States Food and Drug Administration: Publications

Comparison of five methods for calculating gas chromatographic peaks (disc integration, triangulation, peak height X width at half height, R_t X peak height, and peak height) shows no significant difference in the calculated results when aldrin, heptachlor epoxide, and dieldrin are injected into a gas chromatograph equipped with electron capture detector.

Problems are associated with the calculation of toxaphene, chlordane, DDT, and BHC. The author makes suggestions for calculating these four residues when present individually and in combinations with other pesticides. Use of the last four toxaphene peaks compares favorably with results obtained by using the entire toxaphene curve. …

Analysis Of Pesticide Residues By Polarography, Raymond J. Gajan

United States Food and Drug Administration: Publications

Polarography is a rapid, sensitive, and relatively specific technique that can be applied to pesticide residue analysis. The technique should also prove a valuable tool in overall pesticide research, such as monitoring new columns, studying kinetics, identifying and determining metabolites, assaying primary pesticide standards, and conducting stability studies.

Diphenylamine-Zinc Chloride As A Chromogenic Agent For The Detection Of A Mixture Of Ddt, Chlordane, And Toxaphene On Thin Layer Chromatograms, Lewis J. Faucheux Jr.

United States Food and Drug Administration: Publications

Diphenylamine-ZnCI, has been evaluated as a chromogenic agent for detection of toxaphene, DDT, and chlordane on Al₂O₃ a thin layer plates. Characteristic colors were obtained for these pesticides; a lower level of about 5 μg was detectable. Color reactions of 34 pesticides at the 20 μg level are presented.

Pesticide Residues, J. William Cook, Sidney Williams

United States Food and Drug Administration: Publications

METHODOLOGY for residue analysis has advanced rapidly during the current review period, from November 1962 through October 1964. Notable progress has been made in the development and refinement of methods of analysis by which any or all of a large number of pesticide residue chemicals can be detected and measured in one general operation. This is of particular significance because great interest has developed-outside the scientific community as well as within - in the possible presence of pesticide chemicals in all parts of our environment, including man himself. Only by the use of improved methodology will it be possible to …

Exposure To Parathion Effect On General Population And Asthmatics, Robert S. Ganelin, Cipriano Cueto Jr., G. Allen Mail

United States Food and Drug Administration: Publications

There has been much lay and medical concern regarding toxic effects of insecticides on the general population. In addition to direct toxic effects, it is suspected that insecticidal application has deleterious physical effects on persons with respiratory diseases. To evaluate some of these problems, the authors have attempted to quantitate actual absorption, symptoms, and laboratory evidence of intoxication in persons with varying degrees of exposure to parathion. By means of controlled observations, the respiratory effect of application of this compound on persons with bronchial asthma was also measured. The results suggest that the effect of this chemical on the general …

Application Of Oscillographic Polarography To Determination Of Organic Phosphorus Pesticide Residues, Raymond J. Gajan

United States Food and Drug Administration: Publications

Some organic phosphorus pesticides have been determined successfully by polarography (1-7). However, in most cases the methods were used to determine the pesticide in commercial formulations. Little has been reported on the polarographic determination of microgram amounts of these pesticides such as those encountered in pesticide residue analysis.

Many of the methods used for the determination of these pesticides are nonspecific. They are based on cholinesterase assay (8- 12), radioactive tracer analysis (13, 14), total phosphorus (15-17), and paper chromatography (18-24).

In this paper we will discuss the polarography of Systox, Di-Syston, and· Thimet and some of their oxidation products, …

Swine Brucellosis And Human Health, Us Public Health Service

United States Food and Drug Administration: Publications

Swine brucellosis is caused by Brucella suis, a strain of bacteria which also cau ses human brucellosis, or undulant fever. T his disease is an imp 0 r tan t public health problem which affects thousands of farmers, livestock handlers, meat processors, and butchers .. The U. S. Department of Agriculture estimates that 6.15 percent of the 1.8 million swine herds in the Nation are infected with brucellosis. This represents about 131,000 in f e c ted herds on farms, where some 579,000 farm people come into daily c ontact with these herds. The infection rate among these rural persons …