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Pharmaceutics and Drug Design

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Full-Text Articles in Pharmacy Administration, Policy and Regulation

2016 Touro College Of Pharmacy Senior Yearbook, College Of Pharmacy Apr 2016

2016 Touro College Of Pharmacy Senior Yearbook, College Of Pharmacy

Touro Yearbooks

2016 College of Pharmacy Senior Yearbook


An Introduction To Drugs And The Neuroscience Of Behavior, Adam J. Prus Jan 2014

An Introduction To Drugs And The Neuroscience Of Behavior, Adam J. Prus

Books

This up-to-date text provides an introductory overview of the nervous system actions and behavioral effects of the major classes of psychoactive drugs, using pedagogy unique among pharmacology texts to make the topic approachable.


Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley Apr 2013

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …


Nonclinical Development Needs And Regulatory Requirements For Multipurpose Prevention Technologies: A Primer, Joseph W. Romano, Martha Brady, Judy Manning Jan 2012

Nonclinical Development Needs And Regulatory Requirements For Multipurpose Prevention Technologies: A Primer, Joseph W. Romano, Martha Brady, Judy Manning

HIV and AIDS

This summary outlines key development elements that will be necessary for various configurations of multipurpose prevention products for the simultaneous prevention of HIV, sexually transmitted infections, and/or pregnancy.


Shaping The Operations Research Agenda For Antiretroviral-Based Prevention Products For Women: Gels And Rings, Martha Brady, C. Elizabeth Mcgrory Jan 2012

Shaping The Operations Research Agenda For Antiretroviral-Based Prevention Products For Women: Gels And Rings, Martha Brady, C. Elizabeth Mcgrory

HIV and AIDS

This report summarizes discussions from a two-day international experts consultation meeting in 2012 on preparing for the successful introduction of women-centered antiretroviral-based HIV prevention methods. It examines the limits and expectations of operations research in antiretroviral health technologies.


A System Dynamics Model Of Pharmaceutical Opioids: Medical Use, Diversion, And Nonmedical Use, Teresa Schmidt, Wayne Wakeland, J. David Haddox Jul 2011

A System Dynamics Model Of Pharmaceutical Opioids: Medical Use, Diversion, And Nonmedical Use, Teresa Schmidt, Wayne Wakeland, J. David Haddox

Complex Systems Faculty Publications and Presentations

A dramatic rise in the nonmedical of pharmaceutical opioids has presented the United States with a substantial public health problem. Nonmedical use of prescription pain relievers has become increasingly prevalent in the US over the last two decades, and diversion of medicines obtained by prescription is assumed to be a major source of supply for nonmedical opioid use. Policymakers striving to protect population health by ameliorating the adverse outcomes of nonmedical use of opioid analgesics could benefit from a systems-level model which reflects the complexity of the system and incorporates the full range of available data. To address this need, …


Constructing A Critical Path For Product Development, Commercialization, And Access, Martha Brady Jan 2011

Constructing A Critical Path For Product Development, Commercialization, And Access, Martha Brady

HIV and AIDS

This brief discusses the Council's health technologies development and the product development path from conceptualization to market. It defines the steps in the Critical Path Framework, and examines activities at the preclinical and clinical stage.


Psychiatric Taxonomy, Psychopharmacology And Big Pharma, Lisa Cosgrove Nov 2010

Psychiatric Taxonomy, Psychopharmacology And Big Pharma, Lisa Cosgrove

Counseling, School Psychology & Sport Faculty Publication Series

Clinicians practicing today need to be aware of the ways in which the current industry-dominated climate may undermine the integrity of the scientific process and, thus, may compromise patient care. In the mental health field, corporate sponsorship bias can affect psychiatric taxonomy and clinical Practice Guidelines (CPG). Financial conflicts of interest (FCOI) can occur when there are financial associations between researchers, authors, or panel members developing psychiatric diagnostic and treatment guidelines, and the pharmaceutical industry, or when randomized clinical trials (RCTs) are industry funded. Therefore, clinicians need to be especially vigilant about the informed consent process when patients are prescribed …


Undue Pharmaceutical Influence On Psychiatric Practice, Lisa Cosgrove, Harold J. Bursztajn May 2010

Undue Pharmaceutical Influence On Psychiatric Practice, Lisa Cosgrove, Harold J. Bursztajn

Counseling, School Psychology & Sport Faculty Publication Series

Within the past few years, increasing concerns have arisen about the ways in which corporate sponsorship of clinical trials and continuing medical education activities may bias the information that is published and disseminated about the benefits and risks of medications. Questions have also been raised about the extent of industry influence on the American Psychiatric Association’s diagnostic and treatment guidelines—namely, its DSM and Clinical Practice Guidelines.


Incentives For Orphan Drug Research And Development In The United States, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Sheryl L. Szeinbach, Jay Visaria Dec 2008

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 …