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  • 1
    Electronic Resource
    Electronic Resource
    Springer
    Investigational new drugs 1 (1983), S. 253-258 
    ISSN: 1573-0646
    Keywords: bisantrene ; CL216,942 ; pharmacokinetics in humans
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The pharmacokinetics of bisantrene, 9,10-anthracenedicarboxaldehyde bis ((4,5-dihydro-1 H-imidazol-2-yl) hydrazone) dihydrochloride were evaluated during a Phase I clinical investigation. Bisantrene at doses of 20 to 280 mg/m2 was administered by variable infusion rates to nine patients with advanced metastatic cancer. Bisantrene's plasma clearance followed a triexponential pattern with a harmonic mean terminal half-life (t1/2 γ) of 26 h. The steady state volume of distribution (Vd ss ) was large, averaging 627 l/m2. Plasma clearance averaged 42.6±6.7 l/h/m2. The cumulative urinary excretion of bisantrene was 3.6±1.6% at 48 h.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-0646
    Keywords: bisantrene ; hypersensitivity ; histamine release
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Nine of ninety-three patients receiving Bisantrene on an every three week schedule developed an anaphylactoid reaction with a variety of symptoms. Most reactions occurred in patients who had multiple exposures to Bisantrene. Investigatiors utilizing Bisantrene in ongoing clinical trials should be aware of this life threatening toxicity.
    Type of Medium: Electronic Resource
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  • 3
    Publication Date: 2019-07-13
    Description: Probabilistic Risk Assessment (PRA) is a modeling tool used to predict potential outcomes of a complex system based on a statistical understanding of many initiating events. Utilizing a Monte Carlo method, thousands of instances of the model are considered and outcomes are collected. PRA is considered static, utilizing probabilities alone to calculate outcomes. Dynamic Probabilistic Risk Assessment (dPRA) is an advanced concept where modeling predicts the outcomes of a complex system based not only on the probabilities of many initiating events, but also on a progression of dependencies brought about by progressing down a time line. Events are placed in a single time line, adding each event to a queue, as managed by a planner. Progression down the time line is guided by rules, as managed by a scheduler. The recently developed Integrated Medical Model (IMM) summarizes astronaut health as governed by the probabilities of medical events and mitigation strategies. Managing the software architecture process provides a systematic means of creating, documenting, and communicating a software design early in the development process. The software architecture process begins with establishing requirements and the design is then derived from the requirements.
    Keywords: Statistics and Probability
    Type: GRC-E-DAA-TN28535 , 2016 Human Research Program Investigators'' Workshop; Feb 08, 2016 - Feb 11, 2016; Galveston, TX; United States
    Format: application/pdf
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  • 4
    Publication Date: 2019-07-13
    Description: No abstract available
    Keywords: Statistics and Probability
    Type: JSC-CN-38519 , 2017 NASA Human Research Program Investigators'' Workshop (HRP IWS 2017) Annual Meeting; Jan 23, 2017 - Jan 26, 2017; Galveston, TX; United States
    Format: application/pdf
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  • 5
    Publication Date: 2019-07-13
    Description: In 2016, the Integrated Medical Model (IMM) v4.0 underwent an extensive external review in preparation for transition to an operational status. In order to insure impartiality of the review process, the Exploration Medical Capabilities Element of NASA's Human Research Program convened the review through the Systems Review Office at NASA Goddard Space Flight Center (GSFC). The review board convened by GSFC consisted of persons from both NASA and academia with expertise in the fields of statistics, epidemiology, modeling, software development, aerospace medicine, and project management (see Figure 1). The board reviewed software and code standards, as well as evidence pedigree associated with both the input and outcomes information. The board also assesses the models verification, validation, sensitivity to parameters and ability to answer operational questions. This talk will discuss the processes for designing the review, how the review progressed and the findings from the board, as well as summarize the IMM project responses to those findings. Overall, the board found that the IMM is scientifically sound, represents a necessary, comprehensive approach to identifying medical and environmental risks facing astronauts in long duration missions and is an excellent tool for communication between engineers and physicians. The board also found IMM and its customer(s) should convene an additional review of the IMM data sources and to develop a sustainable approach to augment, peer review, and maintain the information utilized in the IMM. The board found this is critically important because medical knowledge continues to evolve. Delivery of IMM v4.0 to the Crew Health and Safety (CHS) Program will occur in the 2017. Once delivered for operational decision support, IMM v4.0 will provide CHS with additional quantitative capability in to assess astronaut medical risks and required medical capabilities to help drive down overall mission risks.
    Keywords: Statistics and Probability
    Type: GRC-E-DAA-TN38711 , 2017 NASA Human Research Program Investigators'' Workshop (HRP IWS 2016); Jan 23, 2017 - Jan 26, 2017; Galveston, TX; United States
    Format: application/pdf
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