Regulation of the Power Sector
Regulation of the Power Sector

Author: Ignacio J. Pérez-Arriaga

Publisher: Springer Science & Business Media

Published: 2014-02-26

Total Pages: 735

ISBN-13: 1447150341

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Regulation of the Power Sector is a unified, consistent and comprehensive treatment of the theories and practicalities of regulation in modern power-supply systems. The need for generation to occur at the time of use occasioned by the impracticality of large-scale electricity storage coupled with constant and often unpredictable changes in demand make electricity-supply systems large, dynamic and complex and their regulation a daunting task. Arranged in four parts, this book addresses both traditional regulatory frameworks and also liberalized and re-regulated environments. First, an introduction gives a full characterization of power supply including engineering, economic and regulatory viewpoints. The second part presents the fundamentals of regulation and the third looks at the regulation of particular components of the power sector in detail. Advanced topics and subjects still open or subject to dispute form the content of Part IV. In a sector where regulatory design is the key driver of both the industry efficiency and the returns on investment, Regulation of the Power Sector is directed at regulators, policy decision makers, business managers and researchers. It is a pragmatic text, well-tested by the authors’ quarter-century of experience of power systems from around the world. Power system professionals and students at all levels will derive much benefit from the authors’ wealth of blended theory and real-world-derived know-how.

Understanding Regulation
Understanding Regulation

Author: Robert Baldwin

Publisher: Oxford University Press on Demand

Published: 2012

Total Pages: 563

ISBN-13: 0199576084

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An introduction to the practical and theoretical issues that are central to the study of regulation, which a particular focus on contested areas and how they are dealt with.

Principles of Financial Regulation
Principles of Financial Regulation

Author: John Armour

Publisher: Oxford University Press

Published: 2016

Total Pages: 698

ISBN-13: 0198786476

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Examining the subject from a holistic and multidisciplinary perspective, Principles of Financial Regulation considers the underlying policies and the objectives of financial regulation.

Design Fundamentals for Low-Voltage Distribution and Control
Design Fundamentals for Low-Voltage Distribution and Control

Author: Frank Kussy

Publisher: Routledge

Published: 2017-11-22

Total Pages: 417

ISBN-13: 1351455966

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Design Fundamentals for Low-Voltage Distribution and Control provides practical guidelinesfor all aspects of this vital topic. Linking theoretical principles with real hardware designs,the book will help engineers meet safety and regulatory standards, reduce redesign costs,shorten product development and testing cycles, and develop more reliable, efficientequipment.This outstanding reference highlights the determination of reactance and resistances of conductors... discusses heat transfer problems in industrial apparatus . .. and considers shortcircuit and ground fault calculations as well as temperature rise and forces occurring underfault conditions.Design Fundamentals for Low-Voltage Distribution and Control applies thermodynamicprinciples to electrical equipment, including coverage of heat transfer equations, calculationexamples for conductor sizes, and insulation. It provides empirical models to show howhigher order theoretical equations can be practically approximated . . . and includes samplecalculations for magnet size, circuit breakers, fault current, arc interruption, and other propertiesand equipment.In addition, the book compares design requirements for both U.S. and European equipment.Featuring numerous equations, graphs, tables, test procedures, and diagrams, Design Fundamentalsfor Low-Voltage Distribution and Control is an invaluable practical guide for electricaland electronics, design, project, and power engineers involved with the design andapplication of electrical apparatus; and graduate students of electrical engineering, powerengineering, and electro technology.

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Sarwar Beg

Publisher: Academic Press

Published: 2019-03-27

Total Pages: 450

ISBN-13: 0128163720

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Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Regulatory Affairs for Biomaterials and Medical Devices
Regulatory Affairs for Biomaterials and Medical Devices

Author: Stephen F. Amato

Publisher: Elsevier

Published: 2014-10-27

Total Pages: 203

ISBN-13: 0857099205

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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Industrial Steam Systems
Industrial Steam Systems

Author: Mojtaba Sabet

Publisher: CRC Press

Published: 2016-02-03

Total Pages: 235

ISBN-13: 1498724698

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This clear, easy-to-follow handbook is a useful resource for engineers, architects, and plant operators. A one-stop reference for beginners and advanced readers alike, it describes industrial steam systems design and operation in simple steps. The book explains the system fundamentals, system setup, and required equipment, building, mechanical, and other code requirements, and details the execution of a sample project. It also explains the equipment operation principle and describes best design practices for system setup, piping and instrumentation, equipment sizing, pipe sizing, and equipment selection.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Author: John Geigert

Publisher: Springer

Published: 2019-05-08

Total Pages: 446

ISBN-13: 3030137546

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Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.