Center for Biologics Evaluation and Research

About: Center for Biologics Evaluation and Research is a facility organization based out in Silver Spring, Maryland, United States. It is known for research contribution in the topics: Virus & Vaccination. The organization has 3024 authors who have published 4648 publications receiving 228078 citations. The organization is also known as: CBER.

Secretory and Endocytic Pathways Converge in a Dynamic Endosomal System in a Primitive Protozoan

Abstract: Leishmania are a group of primitive eukaryotic trypanosomatid protozoa that are apically polarized with a flagellum at their anterior end. Surrounding the base of the flagellum is the flagellar reservoir that constitutes the site for endocytosis and exocytosis in these organisms. In the present study, we define a novel multivesicular tubular compartment involved in the intracellular trafficking of macromolecules in Leishmania. This dynamic structure appears to subtend the flagellar reservoir and extends towards the posterior end of the cell. Functional domains of several surface-expressed proteins, such as the gp63 glycosyl phosphatidyl inositol anchor and the 3′nucleotidase/nuclease transmembrane domain were fused to green fluorescent protein. These chimeric proteins were found to traffic through the secretory pathway and, while reaching their intended destinations, also accumulated within the intracellular tubular compartment. Using various compounds that are efficient fluid-phase markers used to track endocytosis in higher eukaryotes, we showed that this tubular compartment constitutes an important station in the endocytic pathway of these cells. Based on our functional observations of its role in the trafficking of expressed proteins and endocytosed markers, this compartment appears to have properties similar to endosomes of higher eukaryotes.

Pharmacist Involvement in Healthy People 2010

Abstract: OBJECTIVE To review opportunities through which pharmacists can help the United States achieve its public health goals as expressed in Healthy People 2010, a document issued by the federal government that expresses the areas of focus for Americans in the first decade of the 21st century. SUMMARY Healthy People 2010 provides general goals for 10 leading health indicators (such as tobacco use, overweight and obesity, and immunizations), and these are then further subdivided into 28 focus areas, many of them with quantifiable goals (such as, "Reduce hospitalization rates for three ambulatory care-sensitive conditions-pediatric asthma, uncontrolled diabetes, and immunization-preventable pneumonia and influenza."). As health care professionals, pharmacists have the responsibility to help the country meet these goals. Ideas for increased pharmacist involvement are described in the article, including the conduct of screening programs and provision of specialized services that focus on such areas as hypertension, diabetes, asthma, patient education, smoking cessation, or general medication management. Pharmacists can build their efforts in these and similar areas by collaborating with physicians and other appropriate professionals, identifying target patients who have obtained services at the pharmacy, contacting patients in at-risk populations within the pharmacy's patient base and/or the community, choosing and monitoring an objective of interest, and maintaining efforts for sustained time periods. CONCLUSION The message of Healthy People 2010 is that the health of the individual is closely linked to the health of the community and hence the health of the nation. Pharmacists, uniquely positioned as the most accessible health care providers in the community, can dedicate their considerable strengths toward using Healthy People 2010 as a tool to organize their own efforts and motivate their patients.

Comparing data mining methods on the VAERS database.

Abstract: Purpose Data mining may enhance traditional surveillance of vaccine adverse events by identifying events that are reported more commonly after administering one vaccine than other vaccines. Data mining methods find signals as the proportion of times a condition or group of conditions is reported soon after the administration of a vaccine; thus it is a relative proportion compared across vaccines, and not an absolute rate for the condition. The Vaccine Adverse Event Reporting System (VAERS) contains approximately 150 000 reports of adverse events that are possibly associated with vaccine administration. Methods We studied four data mining techniques: empirical Bayes geometric mean (EBGM), lower-bound of the EBGM's 90% confidence interval (EB05), proportional reporting ratio (PRR), and screened PRR (SPRR). We applied these to the VAERS database and compared the agreement among methods and other performance properties, particularly focusing on the vaccine–event combinations with the highest numerical scores in the various methods. Results The vaccine–event combinations with the highest numerical scores varied substantially among the methods. Not all combinations representing known associations appeared in the top 100 vaccine–event pairs for all methods. Conclusions The four methods differ in their ranking of vaccine–COSTART pairs. A given method may be superior in certain situations but inferior in others. This paper examines the statistical relationships among the four estimators. Determining which method is best for public health will require additional analysis that focuses on the true alarm and false alarm rates using known vaccine–event associations. Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance. Copyright © 2005 John Wiley & Sons, Ltd.