Pharmacy Administration, Policy and Regulation Commons^™

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Fda Approves 18 New Molecular Entities/Biologics, Rodney Richmond

Faculty Research ​and Publications

No abstract provided.

Descriptive Study Of Prescriptions For Opioids From A Suburban Academic Emergency Department Before New York's I-Stop Act., Lyncean Ung, Ronald Dvorkin, Steven Sattler, David P. Yens

The School of Health Sciences Publications and Research

Introduction: Controlled prescription opioid use is perceived as a national problem attributed to all specialties. Our objective was to provide a descriptive analysis of prescriptions written for controlled opioids from a database of emergency department (ED) visits prior to the enactment of the I-STOP law, which requires New York prescribers to consult the Prescription Monitoring Program (PMP) prior to prescribing Schedule II, III, and IV controlled substances for prescriptions of greater than five days duration.

Methods: We conducted a retrospective medical record review of patients 21 years of age and older, who presented to the ED between July …

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 …

Childhood Obesity And Familial Hypercholesterolemia: Genetic Diseases That Contribute To Cardiovascular Disease, Alyssa Caudle

Senior Honors Theses

Childhood obesity occurs as the result of an imbalance between caloric intake and energy expenditure. Genetic risk factors for obesity have become an area of research due to its permanency. Mutated genes such as Fat Mass and Obesity Associated (FTO), Leptin (LEP), Leptin Receptor (LEPR), Melanocortin 4 Receptor (MC4R), Adiponectin C1Q and Collagen Domain Containing (ADIPOQ), Proprotein Convertase Subtilisin/Kexin Type 1 (PCSK1), and Peroxisome Proliferator-Activated Receptor Gamma (PPARG) all contribute to the development of childhood obesity. In the presence of high cholesterol caused by obesity, the genetic condition known as familial hypercholesterolemia is exacerbated. Familial hypercholesterolemia is caused by a …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

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 …

Incentives For Orphan Drug Research And Development In The United States, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Sheryl L. Szeinbach, Jay Visaria

Pharmacy Faculty Articles and Research

Background: The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.

Methods: Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during …

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

Seton Hall University Dissertations and Theses (ETDs)

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Book Review, Jennifer L. Frizzell

RISK: Health, Safety & Environment (1990-2002)

Review of the following: THOMAS SZASZ, OUR RIGHT TO DRUGS: THE CASE FOR A FREE MARKET. (Praeger 1992) [164 pp.] Notes, bibliography, name index, notes, preface, subject index. LC: 91-30378; ISBN: 0-275-94216-3. [Cloth $19.95. P.O. Box 5007, Westwood CT 06881-9990.]

Risk Perception And Drug Safety Evaluation, Ilan B. Vertinsky, Donald A. Wehrung

RISK: Health, Safety & Environment (1990-2002)

The authors present a Risk communication framework based on a survey of empirical research concerning public Risk perceptions. They also apply it to the area of pharmaceutical regulation to suggest more effective regulatory strategies.

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 …