Redonda Gail Miller, M.B.A., M.D.
- President, The Johns Hopkins Hospital
- Associate Professor of Medicine
https://www.hopkinsmedicine.org/profiles/results/directory/profile/0005712/redonda-miller
Early in the program arthritis pain patch order naprosyn master card, there was no delineation between medical monitoring and scientific research arthritis in the knee at 30 purchase naprosyn line. Data were considered as scientific discovery as well as information on crew health rheumatoid arthritis kidney purchase naprosyn 500 mg otc. During the Voskhod missions arthritis in dogs after knee surgery purchase discount naprosyn, medical monitoring became an independent element of medical support, separate from scientific research. This 1-day flight of a three-man crew with the participation of the first physician-cosmonaut, B. As human flight continued, increased research efforts emphasized the need for better monitoring and protective measures that would define normal parameters (Table 1). Systems and protocols have evolved to today’s successes with a minimum of serious medical events. Future systems for medical monitoring will have a greater degree of sophistication and automation for data acquisition. During the 40 years of space exploration, two medical monitoring concepts have developed in parallel: that of Russia (formerly U. The Russians developed medical monitoring systems for space flight lasting many months with one to three crews on the Salyut and Mir orbital stations. Operational Concepts A successful mission relies on three independent yet interrelated elements—the spacecraft, the human, and the environment, each of which can impact crew health and safety. The successful function of the human-rated spacecraft relies on system design and performance characteristics (see Chapter 12, General Requirements for Flight Safety). Performance of the human in the space flight environment is dependent on a continuum that begins with stringent selection (Chapter 1), training (Chapter 2), and preflight health monitoring of the crew (Chapter 3). During flight, comprehensive monitoring of all three systems is necessary for timely intervention and application of countermeasures to maintain the integrity and safety of the mission(s). In the postflight period, crew health is 11 monitored in light of readaptation to Earth and guides physical rehabilitation. Goals the primary goals of in-flight medical monitoring are to assess and forecast the crew’s health, safety, and performance; to determine when changes are pathological and not merely adaptive; and to measure environmental parameters that could affect crew health. The human body undergoes significant physiological changes in space; these changes result in new state(s) of physiological function within days to weeks on orbit (see Table 1). Tracking these changes over time and assessing potential impacts on health are critical aspects of medical monitoring. Determine the risk of developing pathological conditions either as a result of adaptive changes or exposure to disease;. Detect detrimental changes that might affect the crew’s ability to maintain homeostasis;. Determine the risks to crew survival in the event of various emergency situations; and. Assess the immediate and long-term consequences on the health, safety, and performance of the crew after flight. Scientific Foundations for In-Flight Medical Monitoring of Crew Health in Space A. Scientific Concepts the monitoring and assessment of crew health and performance is important for assuring the safety of human space flight. This safety is dependent on the proper interaction among systems—the human, the environment, and the spacecraft. Health, according to the definition of the World Health Organization, is not only the absence of disease or physical defects, but also physical, mental, and social well-being. The driving forces include scientific interpretation of health in various cultures, the definition of normal parameters, the importance assigned to various medical findings, and the general principles for creating and operating an in-flight medical monitoring and assessment system. The health care system of Russia is based on the principle of ambulatory evaluation by medical specialists. It has three goals: screening for disease, establishing deviations from health, and predicting future medical risks. The traditional Russian public health care system influenced the development of in-flight medical monitoring of the space program. The approach is to integrate parameters relating to the cosmonaut’s health and those relating to the environment. The predictive approach encompasses examinations that assess the current state of the health of a crewmember and evaluate risks that might appear in the future. Thus the primary care physician, in space medicine referred to as a flight surgeon, evaluates the results of the medical monitoring and is the primary medical specialist for interactions with the crewmember on orbit. The flight surgeon holds private medical conferences with the astronaut to address issues concerning health and well-being and personally monitors all the data transmitted from the spacecraft. General Principles of Medical Monitoring Methods: 3,7,12–16 Guidelines for crewmember performance and supporting medical interventions have been described. These guidelines are implemented based on traditional medical principles and knowledge gained from previous space flight investigations, including availability of new monitoring technologies. The rationale for monitoring of humans during space flight is designed to maintain the mental and physical health of the crew in order to continue the 13,17–20 mission. The experience and knowledge gained on short and long-duration missions have demonstrated that there are physiological and psychological changes, which over time can present health risks to humans in space. In addition to the assessment of the current state of health and environmental factors, space medicine includes the evaluation of the adaptation process in microgravity and the development of pathological changes and associated 18 13,21–24 illnesses. Russian medical monitoring relies on the collection, transmission, processing, and analysis of medical data obtained during the flight. Three types of medical monitoring are identified: continuous, experimental, and unscheduled medical evaluation, as shown in Table 2. Both original and processed data and data collected before and after flight are stored in 25,26 databases. Subjective information (data from audio and video exchanges and medical private communications) is often the sole source of information concerning changes in health status. When it is not possible to substantiate this on the basis of standard medical monitoring and evaluation or periodic detailed examinations, it might be necessary to conduct an emergency evaluation. Data processing and analysis are performed using computational programs and experts’ interpretation of results. This experience has been instrumental in identifying current monitoring capability needs. Diagnostic Aspects of Medical Monitoring Specialists in space medicine have developed a list of specific conditions that might occur as the result of exposure to hazardous factors, including weightlessness. Three types of risks have been described: risk of illnesses; individual physiological changes resulting from space flight and functional and morphological changes in organs that are specific to space flight; and new manifestations resulting from adaptation. Early identification of disease states is sometimes impossible because of the state of the art of medical practice. This has led space medicine specialists to search for new approaches and protocols to identify subtle changes in 28 homeostasis. The latter is extremely 29 important for the development of the predictive health evaluation : Diagnosis and treatment of in-flight illness is presented in Chapter 5 of this volume. Prognostic Aspects of Medical Monitoring Predicting and anticipating the health status of crewmembers is an integral part of medical monitoring. In order to predict the risk for the first human space missions, animals (dogs and monkeys) were sent into space. During the early flights, acquired scientific data was used as the basis for establishing the safety of the next space flights. With missions lasting several months on the Salyut orbital stations, it was necessary to develop a special medical risk assessment program, which was further refined on the Mir station. Forecasting the state of health in space has particular significance during operations of the International Space Station and future interplanetary flights that may last years. Prognosis has a degree of uncertainty, which should be weighed in assessing the risk to a mission. Predicting risks to health 30,31 has three components: deterministic, probabilistic, and random.
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- Acoustic neuroma
Therefore arthritis pain relief cvs order naprosyn 250 mg mastercard, it is important to determine the number of currently diagnosed patients and the accuracy of this number arthritis in dogs stem cell treatment order naprosyn 250 mg visa. Unless an orphan drug company has doctors can arthritis in neck cause ear pain 500 mg naprosyn mastercard, hospitals or medical organizations that will support and increase awareness of the disease rheumatoid arthritis in feet symptoms naprosyn 250 mg low cost, market penetration (and potential sales) could be weak. Especially in relatively small countries like Korea, Taiwan, and Malaysia there may only be a handful of doctors in the country who specialize in the disease. Therefore, their support will be critical both to regulators considering the drug and to the success of the drug’s marketing. This means that satisfied doctors will be particularly persuasive to Asian regulators, especially if they are already known as experts in the field. If a competing product is already available in the country, it is still possible to register a drug as an orphan product and receive approval. However, the new drug will need to be superior to the product currently on the market; data demonstrating this superiority will play a crucial role in the orphan drug designation process. If a competing product is already present in the market, a “product comparison” will be necessary along with the product dossier in order to show superiority over the competitor. The actual registration process for each Asian country is outlined in the following sections of this report. Some Asian countries have an application process specifically for orphan drugs, while other countries do not. Nevertheless, the registration option(s) available in each country will be discussed, as well as application strategies, reimbursement and other important issues. Of orphan drug designations to date, close to half of the drug developers are non-Japanese companies, demonstrating the success of foreign companies in Japan at receiving orphan drug approvals. The majority of the orphan drugs approved in Japan are used for treating infectious diseases, hematological diseases, neuromuscular diseases, and diseases common in children or infants. The drug is used to treat a rare disease or condition affecting less than 50,000 persons in Japan - with a maximum of 4 persons per 10,000 (. It is important to note that if the number of patients affected by the disease is approaching 50,000. If the drug is used to treat a “designated intractable disease” (nanbyou), the number of patients affected by the disease can be as large as 180,000 people. The drug treats a disease or condition for which there are no other drugs/treatments available in Japan or the proposed drug is clinically superior to drugs already available on the Japanese market (in terms of efficacy and safety). The applicant should have a clear product development plan and scientific rationale so that the eventual marketing of the drug in Japan is more likely. The consultation services for “regular” drugs can cost as much as $20,000 for a typical product. In the majority of orphan drug designations, fewer clinical trials in Japan are required for product approval than are required in the West. The applicant may receive financial aid for the collection of supporting data, such as for conducting clinical trials, bridging studies, etc. Specifically, the applicant may receive as much as 50% of the cost of clinical development costs in financial aid, as well as tax exemptions of up to 12% of drug development/research costs Copyright © 2017 Pacific Bridge Medical. The application will be placed on a fast-track approval process, which generally proceeds much more smoothly than that of “regular” drugs. In theory, the fast track approval process takes 10 months while the approval for “regular” drugs takes 12 months. Product renewal for orphan drugs is every 10 years, versus every 4 to 6 years for other drugs. Although the exact fees vary depending on application type, total fees typically go down by about 25%. Shimoaraiso will explain the application process, including what information should be included with the application, which documents need to be translated, and whether any documents need to be revised. Date Attached Data Data on number of Statistical papers, interviews with Japanese doctors, 2 patients medical associations, etc. Explanation of why the drug is clinically superior to drugs already available in Japan (if applicable). Discussion of the scientific rationale supporting the use of 4 Scientific Rationale the drug for the rare disease/condition, including data from non-clinical laboratory studies, clinical investigations, etc. If any doctors in Japan already have experience using the drug, the applicant should ask the doctors to develop a Copyright © 2017 Pacific Bridge Medical. Date Address Name (Seal) To: Minister of Health, Labor and Welfare Source: Drug Approval and Licensing Procedures in Japan 2008 (Jiho, Inc. There is no regulation preventing more than one orphan drug designation and approval for the same indication in Japan. For instance, if a product is already on the market in Japan and designated as an orphan drug for the treatment of Disease A, this does not prevent another drug from receiving orphan drug designation and entering the Japanese Copyright © 2017 Pacific Bridge Medical. Japanese data is considered most supportive in terms of getting the product approved. It is best to target doctors focused on the specific disease/condition your drug treats in order to obtain the strongest support for your product. First, compile a list of potential doctors or Key Opinion Leaders who may be interested in your product. Introduce your orphan drug to these doctors and try to establish good working relationships with them. If a doctor obtains favorable results from your product, they may be willing to write a letter of recommendation to support your orphan drug application. Second, identify any related Japanese medical associations that may be interested in your drug. A representative from the association may also be willing to provide a letter of recommendation for your application if he/she sees the drug as beneficial. Keep in mind that obtaining support from a medical organization may require a small monetary donation ($5,000 $20,000). Doctors hold a very high status in Japanese society and are treated with the utmost authority. Therefore, it can be very difficult to make appointments with doctors, especially if one is requesting a face-to-face meeting. Very careful research by a professional consultant may be required to appropriately network with key doctors and obtain the necessary support. If the request is approved, the designation administrator will notify the applicant of his or her consultation date by phone or fax. The consultation itself takes around 30 minutes with a “sufficient” number of people appropriate to the applicant’s level of need. The applicant should submit five copies of the draft designation application (see next page), with other information attached, such as scientific evidence, research, literature, a list of references etc. Designation Consultation Form To: Person in charge of orphan drug designation, Pharmaceutical and Safety Bureau, Minister of Health, Labor and Welfare Company name Name of consulter (Name of participant and department) Phone number/Fax number Preferred date of consultation First choice: Second choice: Third choice: Name of substance to be designated Anticipated indications Matter to consult Source: Drug Approval and Licensing Procedures in Japan 2008 (Jiho, Inc. The preferred consultation day may not be available Attachment Form 2 Outline of Orphan Drug etc. Name Anticipated indications Name of applicant Target disease Indications of this drug for target disease Copyright © 2017 Pacific Bridge Medical. Sometimes, the company will be able to obtain their answer through these communications without meeting. Based on experience, there is usually a three to four-month wait between applying for a meeting and holding the meeting. The first in-person consultation meeting is normally free; future meetings usually require a fee. Around the time of the third meeting, the company should be able to provide information on how they plan to proceed with the clinical trials. The following other types of sessions are available for general drugs (see Table 5 below): Copyright © 2017 Pacific Bridge Medical. After approval by both groups, the drug is designated and a certificate will be sent to the applicant. Generally, the consultation applicant will be contacted within a few business days of request submission to set the future date of the consultation. At that time, the company will need to confirm the date and time of the consultation as well as the number of people attending. The meeting should begin with the drug company presenting their orphan drug development plan, including the drug development completed to date. This “official record” can be used as supportive information in the new drug application dossier.
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Several conditions are of major importance at the descent module landing site and during evacuation: Crewmembers must be carefully assisted out of the descent module in a way that will prevent injuries and problems with orthostatic intolerance; rheumatoid arthritis disease purchase naprosyn 250 mg fast delivery. Vital signs must be used to identify the need for first aid or expert field care; rheumatoid arthritis leg cramps purchase naprosyn 250 mg online. Limited-isolation or quarantine measures must be directed at limiting contacts and protecting crewmembers from infectious diseases; arthritis rings buy genuine naprosyn. Evacuation procedures must ensure the timely transport of crewmembers to the intermediate airport or arthritis back pain at night generic 500 mg naprosyn visa, if necessary, to a treatment facility (military or civilian hospital) for interim specialized care; and. The readiness of rescue and first aid equipment must be maintained at probable points of descent module landing. The Russian Program for Postflight Medical Monitoring Search and rescue operations, evacuation, dynamic medical monitoring, and remedial and rehabilitation measures performed on crews after completion of space flight are directed toward identifying functional changes or physiological shifts in the cosmonauts and restoring their health. The major objectives of dynamic medical monitoring and remedial and rehabilitation measures in the postflight period are: Determination of the nature, content, scope, and tactics of rehabilitation and other measures during the postflight readaptation period. When necessary, use of remedial and rehabilitation measures during rescue, en route, at the Cosmonaut Training Center, and at the rehabilitation sites. Hygienic/disinfection measures in evacuation vehicles and at sites visited by the crew. Assessment of the efficacy of onboard countermeasures in order to improve them further. Development of recommendations directed toward optimizing the restoration of the professional performance capacity of crewmembers after space flights. Prediction of whether a crewmember will be able to participate in further space flights. Development of recommendations to support effective training of crews for future space flights. The ultimate objective of medical monitoring is determining the nature, scope, and schedules of remedial health measures during the various periods of readaptation. The measures used during the acute period of readaptation are directed at restoring health and treating problems, They include a light regimen of motor activity, prevention of orthostatic disorders. The measures used during the subsequent (subacute) period of readaptation include a light schedule of motor activity with gradual increase to a training schedule, a balanced diet with four meals per day, light morning gymnastics, controlled-pace walking, physical therapy, general and relaxing massages (daily), baths in water saturated with carbon dioxide, pool swimming /aquatic gymnastics, electrical stimulation of the leg muscles, drug therapy (as indicated), and psychological stress reduction. The nature and schedule of remedial health measures used, and the points at which are utilized during evacuation and rehabilitation are prescribed on the basis of a crewmember’s health status. Timelines for use of various measures are established on the basis of results of medical monitoring and are determined by the severity of the adverse changes induced by space flight factors, the state of health and performance capacity of a crewmember, the efficacy of in-flight prophylactic measures against deconditioning, and the conditions and efficacy of the readaptation measures used. The extent to which health and the functional and physical status of crewmembers is restored after use of rehabilitation measures is assessed from the results of a final clinical physiological examination, which is used to derive or adjust individualized plans for subsequent biomedical support. Six months after completion of a space flight, cosmonauts undergo an inpatient medical examination to determine fitness for the next cycle of special training. The purposes of this program are to identify space flight medical risks and their influence on crew health and mission success, to identify medical capabilities that are essential in providing optimal health care during space flight, and to identify the long-term consequences of space travel under specific conditions so that preventive measures can be investigated and instituted. This multifaceted risk management includes elements such as collection and consolidation of medical data from astronauts, cosmonauts, and analogous populations; surveys of informed medical opinion, and comparison of risk management methods used in other organizations. Subcomponents of this program include ground-based longitudinal studies of astronaut health. An epidemiological cohort study is underway to examine the incidence of acute and chronic morbidity and mortality in astronauts and in several control groups over time. A similar but more focused in-flight study to be conducted in parallel will track and analyze the incidence of illness and injury during space flight. Until sufficient medical data from space flight are collected to reach statistical confidence limits, data from various analog populations will continue to be evaluated for comparison and application to space-medicine models. A more profound understanding of the medical risks associated with space flight confers several long-term benefits, among them the ability to apply that understanding to the allocation of program resources and mission planning, to the refinement of medical selection standards, and to the prioritization of biomedical investigations and development of preventive countermeasures. Automated Medical Monitoring and Database Development in the Russian space program Advances in space medicine and associated progress in human performance in space have reached a level that seemed ambitious 30 years ago. However, further progress is difficult to achieve if radical changes are not made in † Transliteration from Russian “sanatorium”; health resort with enhanced and recreation facilities and personnel. The Russian space program uses several facilities of the Ministry of Health; particular resort is selected on an individual basis depending on the specifics of the rehabilitation tasks, time of the year and crew preferences. The amounts of data previously obtained and the rate at which new data are being accumulated (including projections for the future) are so great that it is already difficult to handle them comprehensively. Furthermore, most data are received currently in forms that are unsuitable for integrated processing, complete analysis, and support of scientific conclusions. In many cases, physiological and other data from various phases of training for crewed flights, during the flight itself, and during the postflight period, are obtained by different specialists in different locations. While generally true in the international setting, this situation is not uncommon even within particular space programs. In such conditions, same clinical or physiological parameters may be presented in different formats and units and may even have differing significance, and normal values due to different equipment and/or methods used to obtain them. When the data obtained by various organizations (services) is initially incompatible. The increase in demands made on hardware for collecting data and on results of information processing for immediate reliable assessment of physiological status to enable prediction of future state, especially on long-term flights, makes it important to perform integrated processing of physiological and medical data. These requirements compel development of techniques for more efficient extraction of information from dynamic parameters and for integrated processing of data taken at different times. An effective solution to these problems is the application of certain information processing methodologies and the development of concepts for a centralized computer database 36 containing various parameters and descriptions relating to space flights. The role and place of a database in a system of medical monitoring and medical support of space flights will be determined by the importance and nature of the decisions made at various stages in the work of the medical service. Russia has had experience in developing databases applicable to the phases of training and direct medical support of space flights. The creation of a database on the results of training for and completion of long-term space flights onboard Russian space stations and future space stations is of particular importance. Some specialists believe that such a database will also allow to confirm early indications that a cosmonaut is failing to adapt or is under excessive stress and also of pathological deviations and diseases. To find a solution for any of these problems, medical personnel turn to medical research data. In on-line medical monitoring, there must be compact (concise) representation of changes over time in a large number of parameters and any instance where one of them exceeds the normal limits must be indicated. Prediction will require a great amount of retrospective information which is processed and analyzed using appropriate algorithms from various prognostic models. For diagnosis, along with data obtained in flight, additional specific data is needed on each cosmonaut, such as his or her medical history, results of laboratory and other studies, and data on status and reactions during selection and training. Thus the database in the system of medical monitoring must support the solution of various problems and at the same time meet scientific needs. The two major scientific objectives are to establish new scientific facts and identify new scientific principles for obtaining new knowledge in the area of space medicine; and to improve the medical monitoring and medical support of space flight systems, using near-real-time analysis of information. The files will consist of records, each of which in its turn consists of information from a certain event (for example, the set of measurements of several parameters at a certain moment of time). The records are “time-linked” as well as associated with a particular cosmonaut, and to the specific conditions under which the data were obtained. The records consist of fields containing individual information elements (such as dates, times, parameter values, textual information, and service codes). Different files contain information related to different sets of measured parameters, such as the schedule of events on board, the personal data for each cosmonaut, and the conditions under which medical studies were performed (tests, loadings etc. Thus, it becomes possible to automate retrieval of specific information through programmable queries (period, cosmonaut, type of study, loading, etc. Aside from solving the problems listed above, a centralized database makes it possible to ensure a more detailed and thorough statistical analysis of the medical information obtained not only to enable on-line decisions, but also to identify patterns of physiological reactions to space flight conditions. In addition, this database can be used to support the derivation, implementation, and testing of mathematical models of physiological systems affected by space flight. Russian Biomedical Training Information System the information environment describing the results of biomedical training of cosmonauts for space flight contains approximately 6000 quantitative and qualitative variables, evaluations, conclusions, and curves obtained from approximately 100 types of medical studies, exposures to various factors, and training procedures. The information system is a means for providing automated information support of biomedical training. The main goal of information support of biomedical training is the timely provision of reliable information on all aspects of the state of health and psychophysiological readiness of a cosmonaut to perform the biomedical aspect of the program in an upcoming flight.
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