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Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

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At least 55 records · Page 3

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

Das, H.

Training man for space flight

Cardiovascular reaction during parachute training, vibration exposure, and prolonged confinement and isolation as measure of efficiency and endurance of man for space flight training

CARDIOVASCULAR SYSTEM

Symposium on Technology Status and Trends

The objective of the National Aeronautics and Space Administration's Technology Utilization Program is to identify, document, and transfer to the national economy the technical advances resulting from our space and research programs. These innovations, when properly applied in industry and business, hold great promise for improving our everyday life and contributing to the prosperity of the nation. We believe that the knowledge, progress, and advances associated with aerospace technology contain major potential for industrial applications. The content and method of presenting symposium papers by Marshall and selected contractor personnel have been designed to transfer an awareness of at least some new technology to attendees in nonaerospace fields.

Conference

Spacecraft 2000

The Spacecraft 2000 program has been conceived by NASA with the objective to maintain the U.S. in a strong technical position in the space arena. The program is to involve a cooperative NASA/industry effort with long-range technology development aims. The technology areas addressed are related to spacecraft power, spacecraft energy storage, power management and distribution, autonomous operation-control, onboard systems integration, secondary propulsion, communications technologies, and systems/subsystems technology verification. Aspects of Spacecraft 2000 interactions with industry are discussed, taking into account visitations of NASA personnel to selected industrial concerns, most critical concerns (general), major technical concern, technology drivers for future spacecraft power systems, technology considerations for secondary propulsion, and questions of commercialization. Plans related to a Spacecraft 2000 program formulation are also considered.

Faymon, K. A.

Defining the performance gap: Conducting a self-assessment

This paper presents two different approaches to performing self-assessments of continuous improvement activities. Case Study 1 describes the activities performed by JSC to assess the implementation of continuous improvement efforts at the NASA Center. The JSC approach included surveys administered to randomly selected NASA personnel and personal interviews with NASA and contractor management personnel. Case Study 2 describes the continuous improvement survey performed by the JSC Safety, Reliability, and Quality Assurance (SR&QA) organization. This survey consisted of a short questionnaire (50 questions) administered to all NASA and contractor SR&QA personnel. The questionnaire is based on the eight categories of the President's Award for Quality and Productivity Improvement. It is designed to objectively determine placement on the TQ benchmark and identify a roadmap for improvement.

Braymer, Susan A.

Stress Prediction System

NASA wanted to know how astronauts' bodies would react under various gravitational pulls and space suit weights. Under contract to NASA, the University of Michigan's Center for Ergonomics developed a model capable of predicting what type of stress and what degree of load a body could stand. The algorithm generated was commercialized with the ISTU (Isometric Strength Testing Unit) Functional Capacity Evaluation System, which simulates tasks such as lifting a heavy box or pushing a cart and evaluates the exertion expended. It also identifies the muscle group that limits the subject's performance. It is an effective tool of personnel evaluation, selection and job redesign.

Source record

An all-woman crew to Mars: a radical proposal

It is logical to propose that if a human mission is flown to Mars, it should be composed of an entirely female crew. On the average, women have lower mass and take less volume than males, and use proportionately less consumables. In addition, sociological research indicates that a female crew may have a preferable interpersonal dynamic, and be likely to choose non-confrontational approaches to solve interpersonal problems.

Space Flight/organization & administration

NASA Hydrogen Peroxide Propellant Hazards Technical Manual

The Fire, Explosion, Compatibility and Safety Hazards of Hydrogen Peroxide NASA technical manual was developed at the NASA Johnson Space Center White Sands Test Facility. NASA Technical Memorandum TM-2004-213151 covers topics concerning high concentration hydrogen peroxide including fire and explosion hazards, material and fluid reactivity, materials selection information, personnel and environmental hazards, physical and chemical properties, analytical spectroscopy, specifications, analytical methods, and material compatibility data. A summary of hydrogen peroxide-related accidents, incidents, dose calls, mishaps and lessons learned is included. The manual draws from art extensive literature base and includes recent applicable regulatory compliance documentation. The manual may be obtained by United States government agencies from NASA Johnson Space Center and used as a reference source for hazards and safe handling of hydrogen peroxide.

Baker, David L.

A psychologist's view of validating aviation systems

All systems, no matter what they are designed to do, have shortcomings that may make them less productive than was hoped during the initial development. Such shortcomings can arise at any stage of development: from conception to the end of the implementation life cycle. While systems failure and errors of a lesser magnitude can occur as a function of mechanical or software breakdown, the majority of such problems, in aviation are usually laid on the shoulders of the human operator and, to a lesser extent, on human factors. The operator bears the responsibility and blame even though, from a human factors perspective, error may have been designed into the system. Human factors is not a new concept in aviation. The name may be new, but the issues related to operators in the loop date back to the industrial revolution of the nineteenth century and certainly to the aviation build-up for World War I. During this first global confrontation, military services from all sides discovered rather quickly that poor selection and training led to drastically increased personnel losses. While hardware design became an issue later, the early efforts were primarily focused on increased care in pilot selection and on their training. This actually involved early labor-intensive simulation, using such devices as sticks and chairs mounted on rope networks which could be manually moved in response to control input. The use of selection criteria and improved training led to more viable person-machine systems. More pilots survived training and their first ten missions in the air, a rule of thumb arrived at by experience which predicted ultimate survival better than any other. This rule was to hold through World War II. At that time, personnel selection and training became very sophisticated based on previous standards. Also, many psychologists were drafted into Army Air Corps programs which were geared towards refining the human factor. However, despite the talent involved in these programs and the tremendous build-up of aviation during the war, there were still aircraft designs that were man killers (no sexism implied since all combat pilots were men). One classic design error that was identified fifty years ago was the multipointer altimeter, which could easily be misread especially by a pilot under considerable task load. It has led to flying fully operational aircraft into the terrain. The authors of the research which formally identified this problem put 'Human Errors' in quotes to express their dissatisfaction with the traditional approach to accident investigation. It traditionally places the burden of guilt on the operator. Some of these altimeters still exist in older aircraft to this day.

Stein, Earl S.

Space Station Furnace Facility Management Information System (SSFF-MIS) Development

This report summarizes the chronology, results, and lessons learned from the development of the SSFF-MIS. This system has been nearly two years in development and has yielded some valuable insights into specialized MIS development. General: In December of 1994, the Camber Corporation and Science Applications International Corporation (SAIC) were contracted to design, develop, and implement a MIS for Marshall Space Flight Center's Space Station Furnace Facility Project. The system was to be accessible from both EBM-Compatible PC and Macintosh platforms. The system was required to contain data manually entered into the MIS as well as data imported from other MSFC sources. Electronic interfaces were established for each data source and retrieval was to be performed at prescribed time intervals. The SOW requirement that predominantly drove the development software selection was the dual-platform (IBM-PC and Macintosh) requirement. The requirement that the system would be maintained by Government personnel influenced the selection of Commercial Off-the-shelf software because of its inherent stability and readily available documentation and support. Microsoft FoxPro Professional 2.6 for Windows and Macintosh was selected as the development tool. This is a software development tool that has been in use for many years. It is stable and powerful. Microsoft has since released the replacement for this product, Microsoft Visual FoxPro, but at the time of this development, it was only available on the Windows platform. The initial contract included included the requirement for capabilities relating to the Work- and Organizational Breakdown Structures, cost (plan and actuals), workforce (plan and actuals), critical path scheduling, trend analysis, procurements and contracts, interface to manufacturing, Safety and Mission Assurance, risk analysis, and technical performance indicators. It also required full documentation of the system and training of users. During the course of the contract, the requirements for Safety and Mission Assurance interface, risk analysis, and technical performance indicators were deleted. Additional capabilities were added as reflected in the Contract Chronology below. Modification 4 added the requirement for Support Contractor manpower data, the ability to manually input data not imported from non-nal sources, a general 'health' indicator screen, and remote usage. Mod 6 included the ability to change the level of planning of Civil Service Manpower at any time and the ability to manually enter Op Codes in the manufacturing data where such codes were not provided by the EMPACS database. Modification 9 included a number of changes to report contents and formats. Modification 11 required the preparation of a detailed System Design Document.

Meade, Robert M.