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313 and 2. 038 , respectively. Combining VABP patients from Dori 08, 09, and 10, older age remained a significant predictor of ACM Table 2; prior antibiotic use within 48 hours of baseline and enrollment in Dori 08 the latter consistent with sponsor and FDA analyses also were significant Table 2. Cox Regression Analysis of Risk/Prognostic Factors for All Cause Mortality in Patients With Ventilator Associated Bacterial Pneumonia, Combined Across Studies All Treated Population, Dori 08, 09, and 10Abbreviations: APACHE II, xxx; CI, confidence interval; MRSA, methicillin resistant Staphylococcus aureus; PaO2/FiO2, xxx; VABP, ventilator associated bacterial pneumonia. Cox Regression Analysis of Risk/Prognostic Factors for All Cause Mortality in Patients With Ventilator Associated Bacterial Pneumonia, Combined Across Studies All Treated Population, Dori 08, 09, and 10Abbreviations: APACHE II, xxx; CI, confidence interval; MRSA, methicillin resistant Staphylococcus aureus; PaO2/FiO2, xxx; VABP, ventilator associated bacterial pneumonia. Patient SAEs and AEs as potential components of an ACM+ endpoint were identified via review of the Pfizer Study 311 and Shionogi databases. However, this study specific approach might miss important patient relevant events. An alternative approach utilizes the Medical Dictionary for Regulatory Activities MedDRA Standardized MedDRA Query SMQ tool; SMQs are validated database interrogation tools . The Toxic/Septic Shock SMQ contains multiple, clinically important pneumonia complications eg, sepsis, respiratory failure. A study database could be interrogated readily using this SMQ to define the plus for an ACM+ endpoint. The frequencies of plus events were examined for Shionogi studies using nonfatal toxic/septic shock SMQ AEs including SAEs and SAEs Table 3 is an example, using Dori 08 and 10.

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TOLKIEN AND J. K. ROWLING . Dr. Shobha Ramaswamy, M. A. Schwartz, C. Ben, M. D. Roycik, and Q. X.

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Sterility Testing: Tests performed to determine whether viable microorganisms are present. Commonly, the test involves immersing a component or system or flushing a fluid pathway with sterile microbial growth medium, incubation of the medium under conditions favorable for microbial growth, and observation of turbidity or other indication of microbial growth after a suitable incubation period. Sterilization: A validated process used to render a product free from viable microorganisms. Lower SALs may be validated as sterile in some cases 2. Validation: Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The dose setting methods entail experimentation that leads a manufacturer of the sterile product to a qualified minimum irradiation dose. The general approach when using this type of method is described in ANSI/ AAMI/ISO 11137:2006 and comprises the following steps:Dose setting methodologies involve qualification of the dose based on the actual radiation resistance of microorganism isolated from the product. As a result, these methods provide the lowest possible dose but require more product samples than a dose substantiation method. The ANSI/AAMI/ISO 111372:2006 VDmax methodology allows for substantiation of two preestablished irradiation sterilization dosages: 15 kGy and 25 kGy. AAMI TIR33:2005 provides the flexibility of using seven additional sterilization doses: 17. 5, 20, 22.

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In the second half of the twentieth century, deindustrialization or "economic restructuring" in the West led to poverty, homelessness, and urban decay in formerly prosperous cities. America's "Steel Belt" became a "Rust Belt" and cities such as Detroit, Michigan, and Gary, Indiana began to shrink, contrary to the global trend of massive urban expansion. Such cities have shifted with varying success into the service economy and public private partnerships, with concomitant gentrification, uneven revitalization efforts, and selective cultural development. Under the Great Leap Forward and subsequent five year plans continuing today, the People's Republic of China has undergone concomitant urbanization and industrialization and to become the world's leading manufacturer. Amidst these economic changes, high technology and instantaneous telecommunication enable select cities to become centers of the knowledge economy. A new smart city paradigm, supported by institutions such as the RAND Corporation and IBM, is bringing computerized surveillance, data analysis, and governance to bear on cities and city dwellers.