Informatics: the fuel for pharmacometric analysis

The current informal practice of pharmacometrics as a combination art and science makes it hard to appreciate the role that informatics can and should play in the future of the discipline and to comprehend the gaps that exist because of its absence. The development of pharmacometric informatics has important implications for expediting decision making and for improving the reliability of decisions made in model-based development. We argue that well-defined informatics for pharmacometrics can lead to much needed improvements in the efficiency, effectiveness, and reliability of the pharmacometrics process. The purpose of this paper is to provide a description of the pervasive yet often poorly appreciated role of informatics in improving the process of data assembly, a critical task in the delivery of pharmacometric analysis results. First, we provide a brief description of the pharmacometric analysis process. Second, we describe the business processes required to create analysis-ready data sets for the pharmacometrician. Third, we describe selected informatic elements required to support the pharmacometrics and data assembly processes. Finally, we offer specific suggestions for performing a systematic analysis of existing challenges as an approach to defi ning the next generation of pharmacometric informatics

The North American Free Trade Agreement (NAFTA)

[Excerpt] The North American Free Trade Agreement (NAFTA) has been in effect since January 1, 1994. NAFTA was signed by President George H. W. Bush on December 17, 1992, and approved by Congress on November 20, 1993. The NAFTA Implementation Act was signed into law by President William J. Clinton on December 8, 1993 (P.L. 103-182). NAFTA continues to be of interest to Congress because of the importance of Canada and Mexico as trading partners, and because of the implications NAFTA has for U.S. trade policy under the Administration of President Donald J. Trump. During his election campaign, President Trump stated his desire to renegotiate NAFTA and that he would examine the ramifications of withdrawing from the agreement once he entered into office. He has also raised the possibility of imposing tariffs or a border tax on products from Mexico. This report provides an overview of North American market-opening provisions prior to NAFTA, provisions of the agreement, economic effects, and policy considerations

Clinical metagenomics.

Clinical metagenomic next-generation sequencing (mNGS), the comprehensive analysis of microbial and host genetic material (DNA and RNA) in samples from patients, is rapidly moving from research to clinical laboratories. This emerging approach is changing how physicians diagnose and treat infectious disease, with applications spanning a wide range of areas, including antimicrobial resistance, the microbiome, human host gene expression (transcriptomics) and oncology. Here, we focus on the challenges of implementing mNGS in the clinical laboratory and address potential solutions for maximizing its impact on patient care and public health

Developments in the Safety Science Domain and in Safety Management From the 1970s Till the 1979 Near Disaster at Three Mile Island

Objective: What has been the influence of general management schools and safety research into causes of accidents and disasters on managing safety from 1970 till 1979? Method: The study was limited to original articles and documents, written in English or Dutch from the period under concern. For the Netherlands, the professional journal De Veiligheid (Safety) has been consulted. Results and conclusions: Dominant management approaches started with 1) the classical management starting from the 19th century, with scientific management from the start of the 20st century as a main component. During the interwar period 2) behavioural management started, based on behaviourism, followed by 3) quantitative management from the Second World War onwards. After the war 4) modern management became important. A company was seen as an open system, interacting with an external environment with external stakeholders. These schools management were not exclusive, but have existed in the period together. Early 20th century, the U.S. 'Safety First' movement was the starting point of this knowledge development on managing safety, with cost reduction and production efficiency as key drivers. Psychological models and metaphors explained accidents from ‘unsafe acts’. And safety was managed with training and selection of reckless workers, all in line with scientific management. Supported by behavioural management, this approach remained dominant for many years, even long after World War II. Influenced by quantitative management, potential and actual disasters after the war led to two approaches; loss prevention (up-scaling process industry) and reliability engineering (inherently dangerous processes in the aerospace and nuclear industries). The distinction between process safety and occupational safety became clear after the war, and the two developed into relatively independent domains. In occupational safety in the 1970s human errors thought to be symptoms of mismanagement. The term ‘safety management’ was introduced in scientific safety literature as well as concepts as loose, and tightly coupled processes, organizational culture, incubation of a disaster and mechanisms blinding organizations for portents of disaster scenarios. Loss prevention remained technically oriented. Till 1979 there was no clear relation with safety management. Reliability engineering, based on systems theory did have that relation with the MORT technique as a management audit. The Netherlands mainly followed Anglo-Saxon developments. Late 1970s, following international safety symposia in The Hague and Delft, independent research started in The Netherland

Advancing automation and robotics technology for the space station and for the US economy: Submitted to the United States Congress October 1, 1987

In April 1985, as required by Public Law 98-371, the NASA Advanced Technology Advisory Committee (ATAC) reported to Congress the results of its studies on advanced automation and robotics technology for use on the space station. This material was documented in the initial report (NASA Technical Memorandum 87566). A further requirement of the Law was that ATAC follow NASA's progress in this area and report to Congress semiannually. This report is the fifth in a series of progress updates and covers the period between 16 May 1987 and 30 September 1987. NASA has accepted the basic recommendations of ATAC for its space station efforts. ATAC and NASA agree that the mandate of Congress is that an advanced automation and robotics technology be built to support an evolutionary space station program and serve as a highly visible stimulator affecting the long-term U.S. economy

Skills Academy research report

"This research was commissioned by the Welsh Assembly Government in July 2009 in order to review the development, operation and sustainability of Skills Academy networks across the UK and other relevant countries, to determine the strengths and weaknesses of such networks and to make recommendations to support the policy development of a Skills Academy network in Wales." - overview

Aerospace management techniques: Commercial and governmental applications

A guidebook for managers and administrators is presented as a source of useful information on new management methods in business, industry, and government. The major topics discussed include: actual and potential applications of aerospace management techniques to commercial and governmental organizations; aerospace management techniques and their use within the aerospace sector; and the aerospace sector's application of innovative management techniques