Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria.

For treatment of severe malaria, the World Health Organization recommends 3 mg/kg intravenous artesunate in pediatric patients weighing less than 20 kg. Here we describe the Food and Drug Administration's rationale for selecting 2.4 mg/kg in pediatric patients weighing less than 20 kg based on literature review and independent analyses.

Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

Background: Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification.

Emotive computing may have a role in telecare.

This brief paper sets out arguments for the introduction of new technologies into telecare and lifestyle monitoring that can detect and monitor the emotive state of patients. The significantly increased use of computers by older people will enable the elements of emotive computing to be integrated with features such as keyboards and webcams, to provide additional information on emotional state. When this is combined with other data, there will be significant opportunities for system enhancement and the identification of changes in user status, and hence of need.

Building quality in clinical trials with use of a quality systems approach.

There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product--high-quality data obtained without compromising the protection of human subjects' rights and welfare.

DRASTIC--INSIGHTS: querying information in a plant gene expression database.

DRASTIC--Database Resource for the Analysis of Signal Transduction In Cells (http://www.drastic.org.

Vaccine risk perception among reporters of autism after vaccination: vaccine adverse event reporting system 1990-2001.

Objectives: We investigated vaccine risk perception among reporters of autism to the Vaccine Adverse Event Reporting System (VAERS).

Methods: We conducted structured interviews with 124 parents who reported autism and related disorders to VAERS from 1990 to 2001 and compared results with those of a published survey of parents in the general population.

Results: Respondents perceived vaccine-preventable diseases as less serious than did other parents.

Centromere silencing and function in fission yeast is governed by the amino terminus of histone H3.

Background: Centromeric domains often consist of repetitive elements that are assembled in specialized chromatin, characterized by hypoacetylation of histones H3 and H4 and methylation of lysine 9 of histone H3 (K9-MeH3). Perturbation of this underacetylated state by transient treatment with histone deacetylase inhibitors leads to defective centromere function, correlating with delocalization of the heterochromatin protein Swi6/HP1. Likewise, deletion of the K9-MeH3 methyltransferase Clr4/Suvar39 causes defective chromosome segregation.

Bovine Aspergillosis Produced by the Inoculation of Conidiospores of Aspergillus fumigatus into a Mesenteric or Jugular Vein.

Conidiospores of Aspergillus fumigatus were inoculated during the second trimester of pregnancy into a mesenteric vein of 14 heifers and into a jugular vein of three additional heifers. Heifers were killed at intervals after inoculation. Lesions were confined largely to the placentas, livers, and lungs.