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NASA NTRS1974

A Shuttle/SpaceLab RF environment survey facility

This paper describes some of the basic system considerations of a proposed experiment for monitoring and measuring the global electromagnetic radiation environment. RF spectrum coverage for this spaceborne survey facility is anticipated to be quite broad and will include selected frequency bands ranging from UHF to millimeter waves. By establishing this RF environment survey facility, a broad data base of useful electromagnetic field intensity information will be developed. This, in turn, should help both the regulatory agencies and user community in terms of future frequency planning and system design by avoiding unwarranted interference. It is proposed that this experiment be flown as a future test bed during the Shuttle/Spacelab era for continuously gathering and updating information on earth-emitted electromagnetic emissions on a global scale.

Taylor, R. E.↗

NASA NTRS1995

Orthostatic hypotension: epidemiology, pathophysiology and management

Orthostatic hypotension is characterized by low upright blood pressure levels and symptoms of cerebral hypoperfusion. Whereas orthostatic hypotension is heterogeneous, correct pathophysiologic diagnosis is important because of therapeutic and prognostic considerations. Although therapy is not usually curative, it can be extraordinarily beneficial if it is individually tailored. Management of the Shy-Drager syndrome (multiple-system atrophy) remains a formidable challenge.

Non-NASA Center↗

NASA NTRSDate not supplied

NASA's Research & Development in Airspace Management for Drones, Air Taxis, and Beyond

Today's National Airspace System is extremely safe. Multiple people and organizations are involved in the handling of flights at all phases. We are, however, at the dawn of a new era in aviation where new entrants are emerging from multiple domains. These new entrants will need to be integrated into the airspace safely and given the flexibility to scale. With that integration and flexibility comes the need and responsibility to develop concepts and systems that will work with the regulatory and operational needs of the Federal Aviation Administration while accounting for the needs of industry. NASA is at the leading edge of research, development, and testing across multiple domains to enable the realization of new entrants such as drones, air cargo and taxis, and high altitude vehicles. Addressing the potential for public good coming from these new capabilities is also a NASA focus area. While there has been considerable effort in the engineering aspects of this research, another thrust that is of importance is that of data integration and visualization. With respect to visualization, NASA Ames Research Center has been leading the advancement in data visualization for these new domains and has spent considerable efforts in the exploration of incorporating Augmented and Mixed Reality as a situation awareness platform. This presentation will outline the new developments in airspace integration and tie in NASA's efforts in visualizing the associated operational data.

airspace management↗

NASA NTRS2001

Decreased human circadian pacemaker influence after 100 days in space: a case study

OBJECTIVE: The objectives of this study were (1) to assess the circadian rhythms and sleep of a healthy, 42-year-old male astronaut experiencing microgravity (weightlessness) for nearly 5 months while living aboard Space Station Mir as it orbited Earth and (2) to determine the effects of prolonged space flight on the endogenous circadian pacemaker, as indicated by oral temperature and subjective alertness rhythms, and their ramifications for sleep, alertness, and performance. METHODS: For three 12- to 14-day blocks of time (spread throughout the mission), oral temperatures were taken and subjective alertness was self-rated five times per day. Sleep diaries and performance tests were also completed daily during each block. RESULTS: Examination of the subject's circadian alertness and oral temperature rhythms suggested that the endogenous circadian pacemaker seemed to function quite well up to 90 days in space. Thereafter (on days 110-122), the influence of the endogenous circadian pacemaker on oral temperature and subjective alertness circadian rhythms was considerably weakened, with consequent disruptions in sleep. CONCLUSIONS: Space missions lasting more than 3 months might result in diminished circadian pacemaker influence in astronauts, leading to eventual sleep problems.

manned↗

NASA NTRS1998

Framework for Small-Scale Experiments in Software Engineering: Guidance and Control Software Project: Software Engineering Case Study

Software is becoming increasingly significant in today's critical avionics systems. To achieve safe, reliable software, government regulatory agencies such as the Federal Aviation Administration (FAA) and the Department of Defense mandate the use of certain software development methods. However, little scientific evidence exists to show a correlation between software development methods and product quality. Given this lack of evidence, a series of experiments has been conducted to understand why and how software fails. The Guidance and Control Software (GCS) project is the latest in this series. The GCS project is a case study of the Requirements and Technical Concepts for Aviation RTCA/DO-178B guidelines, Software Considerations in Airborne Systems and Equipment Certification. All civil transport airframe and equipment vendors are expected to comply with these guidelines in building systems to be certified by the FAA for use in commercial aircraft. For the case study, two implementations of a guidance and control application were developed to comply with the DO-178B guidelines for Level A (critical) software. The development included the requirements, design, coding, verification, configuration management, and quality assurance processes. This paper discusses the details of the GCS project and presents the results of the case study.

Hayhurst, Kelly J.↗

NASA NTRS2024

Recommendations on Evidence and Process for Certification of Learning-enabled Components in Aerospace Systems

This report primarily identifies a collection of relevant and necessary evidence for assurance of machine learnt components (MLCs)—also known as learning-enabled components—integrated into aircraft systems, and gives preliminary suggestions on the elements of a certification process that invoke the identified evidence. The main focus is on feedforward neural networks that are static and trained offline through supervised learning. A brief background on the generic elements of the lifecycle of an MLC is given to contextualize the assurance considerations and, consequently, the evidence that is relevant and necessary to support certification. At the level of an MLC, those considerations relate to: (i) the consistency and correctness of MLC contributions to system functions in the context of a validated functional intent; and (ii) the absence of MLC contributions to aircraft-level failure conditions. At an ML model level, confidence in model and data properties contribute to assurance of the containing MLC, in particular: (a) generalizability and robustness of models, in the presence of inputs not previously seen during training, disturbances to inputs, and unexpected inputs; and (b) valid data, i.e., data that are at least representative, relevant, complete, and accurate. Evidence for the above span the elements of the ML lifecycle, and includes, at a minimum, lifecycle artifacts that pertain to: (1) properties of requirements capturing functional intent, safety constraints, and aspects of the intended use and operating environment; (2) model performance, model complexity and design, and algorithm choice; (3) achievement of required performance at the levels of a trained model during model development, a trained model after model development is complete, and a trained model that is transformed into an executable equivalent; (4) model implementation aspects necessary for transforming a trained model into the executable equivalent; (5) integration of the executable trained model into the containing MLC, and eventually the larger system; and, (6) lastly, the verification and validation (V&V) of each of the above. Such V&V lifecycle artifacts themselves include: aspects of coverage, e.g., of various levels of requirements by the input space of the model and the data; traceability (where applicable); application of formal methods for property specification, analysis, and checking. Examples of evidence generation methods and tools further ground the discussion on what constitutes evidence, and the contribution to assurance during certification. The identified assurance considerations and supporting evidence is not a comprehensive set. Additionally, neither what should be considered as sufficient evidence relative to the assigned criticality of an MLC, nor how criticality ought to be determined and adjusted, have been considered in this report. However, suggestions are made for potential activities of the ML lifecycle that are aimed at providing confidence that an MLC can be relied upon when integrated into its containing (aircraft) system. Those activities are proposed as candidate elements of a certification process for MLCs. The main purpose of this report to inform regulatory guidance and consensus standards that may be used to meet the safety intent of the applicable regulations.

Aviation safety↗

NASA NTRS2018

NASA Kennedy Space Center: Contributions to Sea Turtle Science and Conservation

The National Aeronautics and Space Administration (NASA) is a United States (US) federal agency that oversees US space exploration and aeronautical research. NASA's primary launch site, Kennedy Space Center (KSC) is located along the east coast of Florida, on Cape Canaveral and the western Atlantic Ocean. The natural environment within KSC's large land boundaries, not only functions as an extensive safety buffer-area, it performs simultaneously as a wildlife refuge and a national seashore. In the early 1960s, NASA was developing KSC for rocket launches and the US was establishing an awareness of, and commitment to protecting the environment. The US began creating regulations that required the consideration of the environment when taking action on federal land or with federal funds. The timing of the US Endangered Species Act (1973), the US National Environmental Policy Act (1972), coincided with the planning and implementation of the US Space Shuttle Program. This resulted in the first efforts to evaluate the impacts of space launch operation operations on waterways, air quality, habitats, and wildlife. The first KSC fauna and flora baseline studies were predominantly performed by University of Central Florida (then Florida Technological University). Numerous species of relative importance were observed and sea turtles were receiving regulatory review and protection as surveys by Dr. L Ehrhart (UCF) from 1973-1978 described turtles nesting along the KSC beaches and foraging in the KSC lagoon systems. These data were used in the first NASA Environmental Impact Statement for the Space Transportation System (shuttle program) in 1980. In 1982, NASA began a long term ecological monitoring program with contracted scientists on site. This included efforts to track sea turtle status and trends at KSC and maintain protective measures for these species. Many studies and collaborations have occurred on KSC over these last 45 years with agencies (USFWS, NOAA, NAVY), students, and universities (UCF, University of Toronto, Texas A&M, UF). This presentation will review the various studies and collaborations on sea turtles at KSC that include: nest distributions and success, stranding network development, aerial survey testing for nest counts, predator control assessments, the earliest baseline blood chemistry health determinations on nesting females, stress hormones in nesting females, multi-year study of hatchling sex ratios, genetics, species composition, abundance and distribution of in-water juveniles, turtle cold stun response, exterior lighting impacts and control, and satellite tag tracking of post-nesting turtles in the vicinity of near shore shoals and sand mining sites. Through these studies, monitoring, and recommendations, KSC has provided excellent stewardship and protection of the local environment. While conducting its space program mission, KSC has also made significant contributions of information for agencies charged with the conservation and management of these species

Provancha, Jane A.↗

NASA NTRS2020

Architecture and Information Requirements to Assess and Predict Flight Safety Risks During Highly Autonomous Urban Flight Operations

As aviation adopts new and increasingly complex operational paradigms, vehicle types, and technologies to broaden airspace capability and efficiency, maintaining a safe system will require recognition and timely mitigation of new safety issues as they emerge and before significant consequences occur. A shift toward a more predictive risk mitigation capability becomes critical to meet this challenge. In-time safety assurance comprises monitoring, assessment, and mitigation functions that proactively reduce risk in complex operational environments where the interplay of hazards may not be known (and therefore not accounted for) during design. These functions can also help to understand and predict emergent effects caused by the increased use of automation or autonomous functions that may exhibit unexpected non-deterministic behaviors. The envisioned monitoring and assessment functions can look for precursors, anomalies, and trends (PATs) by applying model-based and data-driven methods. Outputs would then drive downstream mitigation(s) if needed to reduce risk. These mitigations may be accomplished using traditional design revision processes or via operational (and sometimes automated) mechanisms. The latter refers to the ‘in-time’ aspect of the system concept. This report comprises architecture and information requirements and considerations toward enabling such a capability within the domain of low altitude highly autonomous urban flight operations. This domain may span, for example, public-use surveillance missions flown by small unmanned aircraft (e.g., infrastructure inspection, facility management, emergency response, law enforcement, and/or security) to transportation missions flown by larger aircraft that may carry passengers or deliver products. Caveat: Any stated requirements in this report should be considered initial requirements that are intended to drive research and development (R&D). These initial requirements are likely to evolve based on R&D findings, refinement of operational concepts, industry advances, and new industry or regulatory policies or standards related to safety assurance.

Young, Steven↗

NASA NTRSDate not supplied

Urban Air Mobility Noise: Current Practice, Gaps, and Recommendations

AN Air Mobility (UAM) is an opportunity for aviation to improve transportation systems across the world. Representative UAM vehicle attributes include electrical vertical takeoff and landing (eVTOL) vehicles that can accommodate up to 6 passengers (or equivalent cargo), are possibly autonomous, perform missions of up to 100 nautical miles at altitudes up to 3000 ft. above ground level, have flight speeds up to 200 knots, and weigh between 800 and 8000 pounds. Along with the many anticipated benefits, there will be noise issues that need to be addressed. In 2018, NASA formed an Urban Air Mobility Noise Working Group (UNWG) to assemble noise experts from industry, universities and government agencies to identify, discuss, and address UAM noise issues. This oral presentation summarizes technology gaps and goals associated with four areas of interest: Tools & Technologies, Ground & Flight Testing, Human Response & Metrics, and Regulation & Policy, and is drawn from a draft white paper [1] by the same title. Tools & Technologies include noise prediction tools and noise reduction technologies that have been developed for conventional rotorcraft and fixed-wing vehicles that may be applicable or need to be modified for UAM. Prediction tools need to be able to account for variable speed rotors and other temporal variation effects that impact community noise. A reprioritization of noise sources needs to be done since UAM vehicles include multiple rotors/propellers, often in proximity to one another and/or the airframe, with dynamic transition, and new noise sources such as electric motors or hybrid-electric propulsion. Scattering and propagation methods need to be developed that include the vehicle components and surfaces near a receiver such as buildings and vertiports. Validation databases are needed to quantify prediction uncertainties. Prediction tools used to evaluate community noise will need source models appropriate for a wide range of UAM vehicles. Existing noise reduction technologies need to be evaluated and new noise reduction technologies should be developed in anticipation of future noise requirements. Although the prediction and treatment of interior cabin noise is a secondary goal, it is recognized that new tools and methods may be needed due to the uniqueness of the vehicle design and the presence of both acoustic and structure-borne loads. Ground & Flight Testing has been a critical part of validating noise reduction technologies and verifying that an air vehicle is ready for certification. UAM vehicles introduce new challenges for test procedures such as different source noise directivity, unsteady sources due to maneuvers, and a variety of takeoff and approach trajectories. The operating environment will be more complex than current aircraft with the introduction of vertiports in populated areas with “urban canyons” making reflections an important part of noise prediction and annoyance. It is expected that new test procedures and measurement methods will be necessary. Consideration will need to be given for both piloted and autonomous operations. Human Response & Metrics may be very different for UAM noise compared to current experience with airport noise. Current metrics used to certify rotorcraft and fixed-wing aircraft may not be as useful for evaluating UAM noise. Operations at lower altitudes may influence annoyance. Psychoacoustic and community testing will be needed to quantify annoyance and assess appropriate metrics. In addition to conventional noise level metrics, considerations such as audibility and temporal variation of the sound may be required. Differences between indoor or outdoor exposure will have an impact with dependence on urban and residential flight paths. Aircraft noise is currently regulated at a national level and typically involves partnerships with the industry to establish regulations. Regulators realize that current policies and procedures may not be appropriate for some of the emerging air vehicles and new procedures may be needed to address UAM noise. Development of new policies and procedures are needed so that local communities do not hastily attempt to establish their own restrictions that will both limit growth of the market and create an inconsistent and confusing regulatory environment. To expedite this development, it is crucial early measurement data are shared through partnership arrangements to support both noise certification and noise modeling/noise assessment. At the same time, an effective engagement strategy should be developed to address local community noise issues associated with UAM vehicles and flight operations as they arise.

urban air mobility↗

NASA NTRS2023

Regulatory response to a hybrid ancestral nitrogenase in Azotobacter vinelandii

Biological nitrogen fixation, the microbial reduction of atmospheric nitrogen to bioavailable ammonia, represents both a major limitation on biological productivity and a highly desirable engineering target for synthetic biology. However, the engineering of nitrogen fixation requires an integrated understanding of how the gene regulatory dynamics of host diazotrophs respond across sequence-function space of its central catalytic metalloenzyme, nitrogenase. Here, we interrogate this relationship by analyzing the transcriptome of Azotobacter vinelandii engineered with a phylogenetically inferred ancestral nitrogenase protein variant. The engineered strain exhibits reduced cellular nitrogenase activity but recovers wild-type growth rates following an extended lag period. We find that expression of genes within the immediate nitrogen fixation network is resilient to the introduced nitrogenase sequence-level perturbations. Rather the sustained physiological compatibility with the ancestral nitrogenase variant is accompanied by reduced expression of genes that support trace metal and electron resource allocation to nitrogenase. Our results spotlight gene expression changes in cellular processes adjacent to nitrogen fixation as productive engineering considerations to improve compatibility between remodeled nitrogenase proteins and engineered host diazotrophs.

nitrogen fixation↗

NASA NTRSDate not supplied

On the Notional Impact of Background Noise on the Human Response to UAVs

Proponents of UAV-based industries would like to think that their aircraft will be incapable of causing annoyance (among other negative responses) in the communities that they serve due to the noise of their vehicles simply not being heard over the existing soundscape. No measures of noise that are in wide use today for aviation take background sound into consideration, and thus would not predict this outcome. This work is an attempt to bridge this gap by looking at past results from psychoacoustic research in which background sounds appear to play a significant role (not just for aviation sources). It includes information on the problem of human auditory detection in general – what is the transductive mechanism of the ear, how does one quantify detectability, etc., and it attempts to make the connection between detectability and annoyance. A notional schematic version of how measures/predictions of these two aspects may be incorporated into a single assessment of noise is given. Overall, detectability is shown to be very complex to predict relative to conventional noise metrics that are used to correlate with human response. Given this, the outlook for the use of measures of detectability in scientific, industrial, and regulatory applications is discussed.

UAV↗

NASA NTRS2026

Computational Materials for Qualification and Certification (CM4QC) Strategy Document: Maturation of Computational Materials Methods for Aviation-Focused Qualification and Certification of Metal Additive Manufacturing (as an Example of Process-Intensive Materials)

Although considerable scientific and technological advances have been made in recent years in additive manufacturing (AM) processes, these advances have not translated into significant market penetration of AM parts within the aviation industry. It is broadly acknowledged that using traditional qualification and certification (Q&C) approaches for AM components is one of the most significant barriers to broader adoption of AM, resulting in high costs, long product development and certification timelines, and complex design iterations during the product development cycle. A new approach is urgently needed. This document lays out a vision for a new Q&C paradigm with increased use of computational materials (CM) methods aimed at decreasing the time and cost of Q&C of process-intensive material (PIM) approaches in the aviation industry, with AM as the immediate use case. This vision was developed with substantial input from industry, regulatory agencies, government research organizations, and academia.

Edward H Glaessgen↗

NASA NTRS1997

Circadian rhythms in human performance and mood under constant conditions

This study explored the relationship between circadian performance rhythms and rhythms in rectal temperature, plasma cortisol, plasma melatonin, subjective alertness and well-being. Seventeen healthy young adults were studied under 36 h of 'unmasking' conditions (constant wakeful bedrest, temporal isolation, homogenized 'meals') during which rectal temperatures were measured every minute, and plasma cortisol and plasma melatonin measured every 20 min. Hourly subjective ratings of global vigour (alertness) and affect (well-being) were obtained followed by one of two performance batteries. On odd-numbered hours performance (speed and accuracy) of serial search, verbal reasoning and manual dexterity tasks was assessed. On even-numbered hours, performance (% hits, response speed) was measured at a 25-30 min visual vigilance task. Performance of all tasks (except search accuracy) showed a significant time of day variation usually with a nocturnal trough close to the trough in rectal temperature. Performance rhythms appeared not to reliably differ with working memory load. Within subjects, predominantly positive correlations emerged between good performance and higher temperatures and better subjective alertness; predominantly negative correlations between good performance and higher plasma levels of cortisol and melatonin. Temperature and cortisol rhythms correlated with slightly more performance measures (5/7) than did melatonin rhythms (4/7). Global vigour correlated about as well with performance (5/7) as did temperature, and considerably better than global affect (1/7). In conclusion: (1) between-task heterogeneity in circadian performance rhythms appeared to be absent when the sleep/wake cycle was suspended; (2) temperature (positively), cortisol and melatonin (negatively) appeared equally good as circadian correlates of performance, and (3) subjective alertness correlated with performance rhythms as well as (but not better than) body temperature, suggesting that performance rhythms were not directly mediated by rhythms in subjective alertness.

NASA Discipline Regulatory Physiology↗

NASA NTRS2016

Human Factors Guidelines for Remotely Piloted Aircraft System (RPAS) Remote Pilot Stations (RPS): Guidelines - Version 1.1

This document contains a list of human factors guidelines for remote pilot stations (RPS) arranged within an organizing structure. The guidelines are intended for the remote pilot stations (RPSs) of remotely piloted aircraft (RPA) that are capable of operating beyond visual line-of-sight in all airspace classes of the United States National Airspace System (NAS). Numerous human factors guidelines and standards for technological systems have been published by standards agencies and regulatory authorities. In compiling this document, the intent was not to reproduce or re-state existing human factors material. Instead, this document focuses on the unique issues of civilian RPAS, and contains guidelines specific to this sector. As a result, it should be seen as a supplement to existing aviation human factors standards and guidance material. Two constraints were used to focus the scope of this document. First, the assumptions contained in the FAA (2013a) UAS roadmap were used to define the responsibilities that will be assigned to the pilot of a RPAS operating beyond visual line-of-sight in the NAS. This in turn, helped to define the tasks that the remote pilot must perform via the RPS, and thereby the required features and characteristics of the RPS. Second, the points of difference between RPAS and conventional aviation were used to further focus the guidelines on the considerations that make piloting a RPA significantly different to piloting a conventional aircraft. Five broad categories of guidelines are identified. These are (1) performance-based descriptions of pilot tasks that must be accomplished via the RPS, (2) information content of displays, (3) descriptions of control inputs, (4) properties of the interface, and (5) high-level design considerations. Some of the guidelines in this document have been adapted from existing RPAS human factors material from several sources, including RTCA publications and Standardization Agreements (STANAGs) published by the North Atlantic Treaty Organization (NATO).

unmanned↗

NASA NTRS1999

Effects of nitric oxide synthase inhibition on sympathetically-mediated tachycardia

The aim of the present study was to determine whether inhibition of nitric oxide (NO) synthesis directly alters the tachycardia produced by sympathetically-derived norepinephrine. The NO synthase inhibitor, N(G)-nitro-L-arginine methyl ester (L-NAME; 50 micromol/kg, i.v.), produced a marked rise in mean arterial blood pressure. This pressor response was associated with a fall in heart rate which involved the withdrawal of cardiac sympathetic nerve activity. The NO-donor, sodium nitroprusside (5 microg/kg, i.v.), produced a pronounced fall in mean arterial blood pressure but only a minor increase in heart rate. The beta-adrenoceptor agonist, isoproterenol (0.5 micromol/kg, i.v.), and the membrane-permeable cAMP analogue, 8-(4-chlorophenylthiol)-cAMP (10 micromol/kg, i.v.), produced falls in mean arterial blood pressure and pronounced increases in heart rate. The indirectly acting sympathomimetic agent, tyramine (0.5 mg/kg, i.v.), produced a pressor response and a tachycardia. The effects of sodium nitroprusside, tyramine, isoproterenol and 8-(4-chlorophenylthiol)-cAMP on mean arterial blood pressure were not markedly affected by L-NAME. However, the tachycardia produced by these agents was considerably exaggerated in the presence of this NO synthesis inhibitor. These findings suggest that L-NAME potentiates the tachycardia produced by sympathetically-derived norepinephrine. The increased responsiveness to norepinephrine may involve (i) a rapid up-regulation of cardiac beta1-adrenoceptors and cAMP signaling in cardiac pacemaker cells due to the loss of the inhibitory influence of cardiac NO, and (ii) the up-regulation of beta1-adrenoceptor-mediated signal transduction processes in response to the L-NAME-induced withdrawal of cardiac sympathetic nerve activity.

NASA Discipline Regulatory Physiology↗

NASA NTRS1994

Integrating human factors knowledge into certification: The point of view of the Internatioanal Civil Aviation Organization (ICAO)

It is appropriate here to repeat the analogy described in the introduction to this paper which is that: The consideration of human factors requirements during the design stage of advanced, new technology systems may be seen as resting over a three-legged stool. The first leg, the equipment that a system will utilize to achieve its goals, has traditionally attracted ergonomic considerations associated with equipment design, usually centered around 'knobs and dials.' Lately, this view has expanded to include the so-called other important aspect of Human Factor's study which deals with the cognitive, behaviorial and social processes of the human operators. Study in this area must be furthered. The second leg of the stool, the procedures to operate the equipment, however, has been largely unaddressed. Procedures are not inherent to equipment, but must be developed. The importance of proper human factors consideration in the design of procedures can not be overstated. Lastly, the third leg of the stool, the certification of personnel who will operate the equipment, is very much underway, but far from being complete. The real quest now, however, is to integrate these three legs into an indivisible one. Finally, and most importantly, this workshop and its topic are extremely timely in that we are at the dawn of the most ambitious development ever undertaken in international civil aviation. This would allow us the rather unique opportunity to put theory into practice in the near future by ensuring that the concepts developed and furthered by this workshop and the follow-up are implemented in the design and certification of the ICAO future CNS/ATM systems described earlier in this paper. Now is the time to incorporate human factors requirements during the certification processes of these systems. This might act as a test to the feasibility of these ideas. Such endeavors represent a challenge for the research, engineering, training, operational and regulatory communities. But there is certainly more to be gained by attempting to meet the challenge rather than refraining from progress by decrying the difficulties involved.

Maurino, Daniel↗

NASA NTRS1996

Transmembrane transport of peptide type compounds: prospects for oral delivery

Synthesis and delivery of potential therapeutic peptides and peptidomimetic compounds has been the focus of intense research over the last 10 years. While it is widely recognized that numerous limitations apply to oral delivery of peptides, some of the limiting factors have been addressed and their mechanisms elucidated, which has lead to promising strategies. This article will briefly summarize the challenges, results and current approaches of oral peptide delivery and give some insight on future strategies. The barriers determining peptide bioavailability after oral administration are intestinal membrane permability, size limitations, intestinal and hepatic metabolism and in some cases solubility limitations. Poor membrane permeabilities of hydrophilic peptides might be overcome by structurally modifying the compounds, thus increasing their membrane partition characteristics and/or their affinity to carrier proteins. Another approach is the site-specific delivery of the peptide to the most permeable parts of the intestine. The current view on size limitation for oral drug delivery has neglected partition considerations. Recent studies suggest that compounds with a molecular weight up to 4000 might be significantly absorbed, assuming appropriate partition behavior and stability. Metabolism, probably the most significant factor in the absorption fate of peptides, might be controlled by coadministration of competitive enzyme inhibitors, structural modifications and administration of the compound as a well absorbed prodrug that is converted into the therapeutically active agent after its absorption. For some peptides poor solubility might present a limitation to oral absorption, an issue that has been addressed by mechanistically defining and therefore improving formulation parameters. Effective oral peptide delivery requires further development in understanding these complex mechanisms in order to maximize the therapeutic potential of this class of compounds.

NASA Discipline Regulatory Physiology↗

NASA NTRS2011

A Human Factors Approach to Bridging Systems and Introducing New Technologies

The application of human factors in aviation has grown to cover a wide range of disciplines and methods capable of assessing human-systems integration at many levels. For example, at the individual level, pilot workload may be studied while at the team level, coordinated workload distribution may be the focal point. At the organizational level, the way in which individuals and teams are supported by training and standards, policies and procedures may introduce additional, relevant topics. A consideration of human factors at each level contributes to our understanding of successes and failures in pilot performance, but this system focused on the flight deck alone -- is only one part of the airspace system. In the FAA's NextGen plan to overhaul the National Airspace System (NAS), new capabilities will enhance flightdeck systems (pilots), flight operations centers (dispatchers) and air traffic control systems (controllers and air traffic managers). At a minimum, the current roles and responsibilities of these three systems are likely to change. Since increased automation will be central to many of the enhancements, the role of automation is also likely to change. Using NextGen examples, a human factors approach for bridging complex airspace systems will be the main focus of this presentation. It is still crucial to consider the human factors within each system, but the successful implementation of new technologies in the NAS requires an understanding of the collaborations that occur when these systems intersect. This human factors approach to studying collaborative systems begins with detailed task descriptions within each system to establish a baseline of the current operations. The collaborative content and context are delineated through the review of regulatory and advisory materials, letters of agreement, policies, procedures and documented practices. Field observations and interviews also help to fill out the picture. Key collaborative functions across systems are identified and placed on a phase-of-flight timeline including information requirements, decision authority and use of automation, as well as level of frequency and criticality.

Kanki, Barbara G.↗