Evaluation Of Administration Research Articles

Benefit-risk assessment for brincidofovir for the treatment of smallpox: U.S. Food and Drug Administration's Evaluation

The development and approval of brincidofovir for the treatment of smallpox, a disease that was eradicated from the world over 40 years ago, has resulted in the second antiviral approved via the Medical Countermeasure Initiative (MCMi) to combat this disease. Approval of brincidofovir required a unique regulatory approach based on the FDA Animal Rule, and development was supported by many years of research and collaboration among academic investigators, the pharmaceutical industry and multiple government agencies. This article summarizes the FDA regulatory pathway and describes the challenges involved.

A Virtual Home for the Virtual Clinical Trial.

Virtual clinical trials (VCTs) can satisfy the need for rigorous clinical trials by using distributed technological solutions that eliminate the need for a physical trial site. This report explores potential benefits of using virtual reality (VR) to provide a “virtual site” for VCTs, a shared immersive hub in which VCT participants could experience elements of the trial and interact with the trial team. VR is a communication technology that has been emerging alongside the development of VCTs, although they have never been merged in a substantial way. Many of the gaps within the VCT paradigm are areas in which VR excels. VR environments are standardized and precisely uniform, the technology allows introduction of an almost endless set of stimuli to participants’ visual and auditory systems, and VR systems are adept at capturing precise movement and behavioral data. Although VR has not yet found its way into VCTs, much of the groundwork for such integration has been laid through research and technological development achieved in the past few years. Future implementation of VR within VCTs could move us from site-less trials to those with a virtual site serving as a hub for trial information provision, interaction with trial representatives, administration of evaluations and assessments, and more.

ANALISIS EVALUASI PENATAUSAHAAN BARANG MILIK DAERAH

The objectives of this study were to evaluate the management of Government Fixed Assets inPegunungan Bintang Regency. The analysis technique used in this study was descriptive analysis.The paper described the Analysis of Regional Property Administration Evaluation in thePegunungan Bintang District Government. The data was shown in tables with numbers andpercentages to be analyzed further with descriptive analysis. In analyzing research data the authoruses qualitative descriptive analysis, also known as content analysis.The results of the study showed that the administration of regional fixed assets in terms of recordingthe assets, The Financial and Asset Management Agency (BPKAD) in Pegunungan BintangRegency has carried out the bookkeeping. This comprises of process of recording regional fixedassets in lists of its users, the inventory cards, and in the database of regional’s fixed assets. Beforerecording the assets, at first, Asset have been identified into its classification based on the type andcodes of regional fixed assets. Thus, in general, it can be concluded that the implementation ofaccounting in the administration of fixed assets in The Financial and Asset Management Agency ofPegunungan Bintang Regency has been well implemented. Evaluation of administration of regionalfixed assets to the inventory on The Financial and Asset Management Agency in PegununganBintang Regency has been carried out in accordance with mandated regulations. This can be seenfrom the evidence of inventory execution such as the existence of recording documents, theDatabase of Inventory, and documented in Inventories Books. In addition, there are reportingdocuments such as List of Inventory Recapitulation and List of inventory Mutations. Evaluation ofadministration of regional fixed assets in terms of reporting to The Financial and AssetManagement Agency in Pegunungan Bintang Regency is carried out in stages based on informationcontained in the list of assets keepers and a list of the authority of its users and keepers. Authoritiesof fixed assets users have to submit assets User Reports every semester, yearly, and 5 years toassets keepers.

Benefit-risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation.

On July 18, 2017, the U.S. Food and Drug Administration (FDA) approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (Vosevi) fixed-dose combination (FDC), an interferon-free, complete regimen for adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing a nonstructural protein 5A (NS5A) inhibitor; and • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Approval was based on an acceptable safety profile and high sustained virological response rates 12 weeks after the end of treatment (SVR12) in two phase 3 clinical trials in subjects previously treated with a direct-acting antiviral (DAA) regimen. In POLARIS-1, 96% of SOF/VEL/VOX-treated subjects achieved SVR12. In POLARIS-4, 98% of SOF/VEL/VOX-treated subjects achieved SVR12. A key and challenging question in evaluating the data was determining the contribution of VOX to SOF/VEL and how this differed depending on the genotype and patient population. In this article, we provide our perspective on the issues considered in making these determinations, especially regarding the POLARIS-4 data in subjects who have previously been treated with a chronic HCV regimen containing sofosbuvir without an NS5A inhibitor. Conclusion: We seek to provide context as to why a broad indication was given for NS5A inhibitor-experienced patients (HCV genotypes 1-6) while the indication for NS5A inhibitor- naïve patients was limited to HCV genotypes 1a and 3 only. (Hepatology 2018;67:482-491).

Bolsa Família e voto na eleição presidencial de 2006: em busca do elo perdido

O presente artigo analisa o impacto de ser beneficiário do Programa Bolsa Família do governo federal na decisão de voto na eleição de 2006 e na avaliação atual do Presidente Lula da Silva e contribui para a crescente literatura que explora o impacto desse programa na distribuição de voto em Lula. Contudo, diferentemente de outros estudos, são analisados aqui dados ao nível individual, testando um modelo estatístico multivariado em uma amostra probabilística nacional usando o Barômetro das Américas de 2008. Os resultados indicam um forte impacto de ser beneficiário do programa no voto em Lula e em avaliações positivas de seu desempenho.

The U.S. Food and Drug Administration's Evaluation of the Safety of Animal Clones

The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDA's claim that its mission to protect and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agency's mission statement presupposes significant normative commitments and judgments. Second, the FDA's risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments.

「水辺の楽校」事業からみた市民・行政の連携による河川管理のあり方に関する研究

The purpose of this research is grasping the present situation of the river management by the partnership between citizen and administrator, and grasping the problem and administrator's evaluation by difference of partnership situations in the project for waterfront schools for fan. Consequently, it turns out that the difference of partnership has drawn the difference of a problem. It turned out that supporting by participation bring about evaluation good for administrator. Because of it, Administrator has to build the system which can share information between a citizen and administration, and should carry out flexible support that correspond to management ability of citizen.

Factors associated with nursing home staff turnover.

This study examines whether, while controlling for local economic conditions, job design and other organizational factors affect facility aide turnover rates in a sample of 250 nursing homes from 10 states. Facility characteristics were largely based on administrator and director of nursing interviews conducted in 1993 as part of the Health Care Financing Administration's evaluation of the Resident Assessment Instrument (RAI) implementation. Aide turnover was significantly reduced by involvement in interdisciplinary care plan meetings. Turnover rates were higher in for-profit homes. Aide involvement in assessments, aide training and workload, case mix severity, payor source mix, and facility size were not significantly related to aide turnover.

Four Criteria of Principal Effectiveness

The need for research in the field of school ad ministrator criteria has been emphas i zed by a number of authorities (7, 10, 11, 12, 16). In spite of the obvious need for research in the se fields, however, the great bulk of work publ i shed to date contributes little to the establishment of sound cri teria. Most of this work consists of accumulations of opinion in one form or another, usually involving the preparation of lists of qualities needed by edu cational administrators (1, 2, 4, 6, 7, 3, 9, 12, 13, 14, 15). Some of these lists arise from surveys based upon national samplings, some upon the opin ion of a single author, some upon commitee re ports, while others are based upon opinions of school teachers in a given high school or school district. These studies make a real contribution to our thinking concerning the nature of the adminis trator's responsibilities and are certainly valuable as far as they go. Their weakness, however, is that they provide no sound, measurable yardsticks against which we can weigh new systems of admin istrator evaluation, selection, or prediction.