Investigation of Regulatory Commissions and Agencies: November 20-21, 24-26, 1958, January 2, and December 9, 1959. pp. 5349-5853. pt. 15. Index PDF Download
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Author: United States. Congress. House. Committee on Interstate and Foreign Commerce
Publisher:
ISBN:
Category : Independent regulatory commissions
Languages : en
Pages :
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Author: United States. Congress. House. Committee on Interstate and Foreign Commerce
Publisher:
ISBN:
Category : Independent regulatory commissions
Languages : en
Pages :
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Book Description
Author: United States. Congress. House. Committee on Interstate and Foreign Commerce. Special Subcommittee on Investigations
Publisher:
ISBN:
Category : Electronic books
Languages : en
Pages : 505
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Book Description
Investigates ICC carrier rate policies and procedures, CAB airline fare standards under the Federal Aviation Act, and the business dealings of Bernard Goldfine as majority stockholder of a company registered with the SEC.
Author: United States. Congress. House. Committee on Interstate and Foreign Commerce
Publisher:
ISBN:
Category : Independent regulatory commissions
Languages : en
Pages :
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Author: George D. Brightbill
Publisher:
ISBN:
Category : Communication and traffic
Languages : en
Pages : 188
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Author:
Publisher:
ISBN:
Category : Indoor air pollution
Languages : en
Pages : 346
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Author: Dennis Jenke
Publisher: John Wiley & Sons
ISBN: 1119605075
Category : Medical
Languages : en
Pages : 468
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Book Description
EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309272246
Category : Science
Languages : en
Pages : 247
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Book Description
The potential for using fusion energy to produce commercial electric power was first explored in the 1950s. Harnessing fusion energy offers the prospect of a nearly carbon-free energy source with a virtually unlimited supply of fuel. Unlike nuclear fission plants, appropriately designed fusion power plants would not produce the large amounts of high-level nuclear waste that requires long-term disposal. Due to these prospects, many nations have initiated research and development (R&D) programs aimed at developing fusion as an energy source. Two R&D approaches are being explored: magnetic fusion energy (MFE) and inertial fusion energy (IFE). An Assessment of the Prospects for Inertial Fusion Energy describes and assesses the current status of IFE research in the United States; compares the various technical approaches to IFE; and identifies the scientific and engineering challenges associated with developing inertial confinement fusion (ICF) in particular as an energy source. It also provides guidance on an R&D roadmap at the conceptual level for a national program focusing on the design and construction of an inertial fusion energy demonstration plant.
Author: T. A. Larson
Publisher: U of Nebraska Press
ISBN: 0803279361
Category : History
Languages : en
Pages : 679
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Book Description
"The History of Wyoming" explains detailed information of territorial and state developments. This second edition also includes the post-World War II chapters containing discussion about the economy, society, culture and politics not included on the previous edition.
Author: William S. Leet
Publisher: University Of California, Division of Agriculture and Natural Resources; Califorinia Sea Grant
ISBN: 9781879906570
Category : Nature
Languages : en
Pages : 596
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Book Description
This 592-page spiral-bound reference provides a baseline of information for all those involved with managing living marine resources in California and chronicles changes that have occurred in many of the state’s fisheries. Organized by marine ecosystems: bays and estuaries, nearshore and offshore. Includes illustrated species descriptions with details of biological knowledge, fishery history, landings data, population status and references. Also includes sections on marine birds and mammals and appendices containing management considerations (by species), a glossary of technical terms and acronyms and fishing gear illustrations. Jointly produced by the California Sea Grant Extension Program and the California Department of Fish and Game following the passage of the Marine Life Protection Act in January 1999.
Author: United States. Taxpayer Advocate Service
Publisher:
ISBN:
Category : Administrative remedies
Languages : en
Pages : 24
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Book Description
