Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these ins...

PROBLEM It is difficult to engage clinicians in continuing medical education that does not focus on clinical expertise. Evolving online technologies (e.g., massive open online courses [MOOCs]) are disrupting and transforming medical education, but few online nonclinical professional development resources exist. APPROACH In August 2013, the Academic Life in Emergency Medicine Web site launched...

BACKGROUND Numerous studies have shown that paranoia is common in the nonclinical population; however, little research has examined whether nonclinical paranoid beliefs change over time, or considered potential reasons for change. AIMS The aim of the present study was therefore to examine naturalistic change in nonclinical paranoid experiences. METHOD 60 participants described an idiosyncra...

This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vaccines by outlining the international regulatory expectations in this area. It should be read in conjunction with the Guidelines on clinical evaluation of vaccines: regulatory expectations (1), in order to complete the understanding of the whole process of vacci...

Nonclinical safety testing of new biotherapeutic entities represents its own challenges and opportunities in drug development. Hot topics in this field have been discussed recently at the 2nd Annual BioSafe European General Membership Meeting. In this feature article, discussions on the challenges surrounding the use of PEGylated therapeutic proteins, selection of cynomolgus monkey as preclinic...

OBJECTIVES Guidelines for antiretroviral therapy (ART) initiation have evolved, but consistently note that adherence problems should be considered and addressed. Little is known regarding the reasons providers delay ART initiation in clinically eligible patients. METHODS In 2009, we surveyed a probability sample of HIV care providers in 582 outpatient facilities in the United States and Puert...

OBJECTIVE No studies have examined psychological functioning among youth with spina bifida (SB) living in a developing country where access to mental health resources is often scarce. This study compared self-reported psychological functioning between youth with SB living in Colombia, South America, and a demographically matched comparison group of healthy Colombian children. METHODS 22 child...

BACKGROUND In recent years, the information environment for patients to learn about physician quality is being rapidly changed by Web-based ratings from both commercial and government efforts. However, little is known about how various types of Web-based ratings affect individuals' choice of physicians. OBJECTIVE The objective of this research was to measure the relative importance of Web-bas...