"Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, and Cosmetic Act (hereinafter, Act), the FDA monitors the manufacturing practices of companies involved in the production of food, drugs, and medical devices. The manufacturing practices used by these companies must comply with certain standards, identified in the Act as "current good manufacturing practices" (hereinafter, CGMP). If a company's practices do not conform with CGMPs, the finished products are considered adulterated, even if the products are technically perfect. The purpose of CGMPs is to assure the safety and efficacy of the finished products

The Legacy Project: Lessons Learned About Conducting Community-Based Research

Collaborative partnerships between community based organizations (CBOs) and university-based researchers can successfully conduct useful HIV prevention research. Collaboratively conducted research contributes to good programs and good science.The Legacy Project is an evaluation of 18 such partnerships. The evaluation found 6 essential elements for successful collaborative community-based research:Thoughtful selection of interventions for evaluationSecondary or alternative research questions incorporated into the research project from the beginningFlexibility to modify or change primary research question mid-studyAppropriate, stable CBO staffingHigh level of university-researcher involvement with both intervention and evaluationAdequate funding for intervention, evaluation and participant tim

Education and Entrepreneurship: Best Learning from Helm Project at Cenderawasih University

In 2013, as part of the Higher Education Leadership and Management national initiative sponsored by US AID, Universitas Cenderawasih proposed an action research project to address the under-employment of UNCEN graduates through purposeful entrepreneurship education. Although entrepreneurship education had been introduced previously at UNCEN, it had never been custom designed to integrate theory and practice appropriate to Papua as part of the formal curriculum.  This paper focuses on the use of core principles of the action research process (ARP) to develop and implement a locally effective curriculum for students enrolled in UNCEN’s Faculty of Economics. A central value underlying the project was the development of a curriculum that could address social inequalities in Papua, specifically the significant under-representation of Papuan native peoples in the entrepreneurship sector.Through a mixed methods approach that used demographic, attitudinal and outcome data as well as observational, interview and focus group data, the ARP team designed an experientially-based learning module, documented implementation of thepilot learning module, evaluated its effectiveness, and developed proposals for improvement and institutionalization. As a result of its action research project, the ARP team suggests that future iterations of the entrepreneurship curriculum at UNCEN should adopt a culturally responsive pedagogy (Gay, 2010; Ladson-Billings, 1995) that addresses the disparities in cultural and social capital shown to be significant in the ARP to entrepreneurship education

The effect of bias instructions on the judgments and interobserver agreements of naive behavior observers

Behavioral scientists have been interested in increasing their understanding of the variables affecting observational data. Concern with improving the reliability of these data has led to numerous investigations of systematic observation methods. One aspect of observational procedure which has begun to receive research and speculative attention has been the area of observer training. Since 1970, investigators have become increasingly interested in identifying variables that might influence the effectiveness of observer training procedures for improving the extent to which observers agree on their rating of behavior. Although empirical findings concerning variables relevant to observer training procedures have only begun to appear in the literature, investigators using systematic observation for data collection have become increasingly aware of the need for organized and specific training experiences for their observers. Suggestions for effective training procedures, based on empirical findings and intuition, have recently been made available (DeMaster, Reid, & Twentyman, 1977; Johnson & Bolstad, 1973; O'Leary & Kent, 1973; Romanczyk, Kent, Diament, & O'Leary, 1973; Wildman & Erickson, 1977; Wildman, Erickson, & Kent, 1975)

A comparison of two training procedures for maintaining inter-rater reliability

Much behavior modification research has relied on the use of human observers to collect data. However, instrumental errors have been found to be associated with the collection of observational data. The present study compared two types of training procedures in which the consistency of the standard, to which the raters were trained to conform, was varied. Sixteen college undergraduates (Ss) without prior experience in observing classroom behavior were trained in the observation of nursery-school children's behavior. All Ss viewed the same 10-minute videotapes of nursery-school children. Seven 60-minute training sessions were conducted using the O'Leary disruptive behavior code. Four pairs of observers in Group I were trained by one graduate student trainer whose ratings were accepted as the standard. Four pairs of observers in Group II were trained by themselves, thus establishing their own standard. Following training, six videotapes were rated by both groups. Videotapes were divided into four 10-minute blocks to permit the collection of overtly and covertly assessed reliabilities for both within-pair and between-pair combinations

Feasibility of incorporating computertailored health behaviour communications in primary care settings

Background We set out to investigate the feasibility of incorporating a computer-tailored health behaviour program into routine care in a group of primary care practices in Rhode Island. Methods Two existing computer programs (physical activity, smoking) that tailored text and graphical feedback to survey responses were combined and adapted for use in primary care directly by patients. Ten primary care practices were recruited and worked closely with project staff to develop a practice-specific plan for incorporating the program into the workflow and office routine. Feasibility was measured by the percentage of patients who used the program during the day of their visit. Results Only one of the ten offices was able to successfully incorporate the program into their office workflow and delivery of routine care. The main categories of barriers to incorporating the computer program into routine care included: • the program was viewed overall as inconsistent with practice workflow • the staff was inexperienced with the program • technical problems with the computer and/or printer • the program placed an additional time burden on staff who already felt overworked. Suggestions for improving the program or the way that it was incorporated into routine care included: • shortening the program • modifying the program’s orientation to a target population (such as patients with hypertension) and incorporating decision-support feedback to help physicians manage the target condition • modifying the program to include other programs pertinent to primary care (for example, depression screening) • selecting patients to use the program, rather than asking all patients to use it. Conclusions After working closely with ten highly motivated primary care offices, we were unable to fully implement a point-of-care health behaviour computer system for patients and providers. Suggestions for disseminating computer-tailored health behaviour communications in primary care settings are discussed

Regional and cellular gene expression changes in human Huntington's disease brain

Huntington's disease (HD) pathology is well understood at a histological level but a comprehensive molecular analysis of the effect of the disease in the human brain has not previously been available. To elucidate the molecular phenotype of HD on a genome-wide scale, we compared mRNA profiles from 44 human HD brains with those from 36 unaffected controls using microarray analysis. Four brain regions were analyzed: caudate nucleus, cerebellum, prefrontal association cortex [Brodmann's area 9 (BA9)] and motor cortex [Brodmann's area 4 (BA4)]. The greatest number and magnitude of differentially expressed mRNAs were detected in the caudate nucleus, followed by motor cortex, then cerebellum. Thus, the molecular phenotype of HD generally parallels established neuropathology. Surprisingly, no mRNA changes were detected in prefrontal association cortex, thereby revealing subtleties of pathology not previously disclosed by histological methods. To establish that the observed changes were not simply the result of cell loss, we examined mRNA levels in laser-capture microdissected neurons from Grade 1 HD caudate compared to control. These analyses confirmed changes in expression seen in tissue homogenates; we thus conclude that mRNA changes are not attributable to cell loss alone. These data from bona fide HD brains comprise an important reference for hypotheses related to HD and other neurodegenerative disease