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Validation is a critical component to programming clinical trial analysis. Essential to effective validation is the programmer's understanding of the data with which they'll be working. If you don't understand how the data is arranged, the values that are reasonable for each variable, and the way the data should behave, you cannot ensure that the final result of your programming effort is complete or even appropriate. Therefore, to be a successful programmer in the pharmaceutical industry, you need to understand validation requirements and to learn how to make the code do the bulk of the work so that your programs are efficient as well as accurate. This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration (FDA). Authors Carol Matthews and Brian Shilling provide practical examples, explanations for why different techniques are helpful, and tips for avoiding errors in your output. Topics addressed include: Validation and pharmaceutical industry overviews Documentation and maintenance requirements discussions General techniques to facilitate validation Data importing and exporting Common data types Reporting and statistics Validating Clinical Trial Data Reporting with SAS is designed for SAS programmers who are new to the pharmaceutical industry as well as for those seeking a good foundation for validation in the SAS programming arena. Readers should have a working knowledge of Base SAS and a basic understanding of programming tasks in the pharmaceutical industry.

Validation is a critical component to programming clinical trial analysis. Essential to effective validation is the programmer's understanding of the data with which they'll be working. If you don't understand how the data is arranged, the values that are reasonable for each variable, and the way the data should behave, you cannot ensure that the final result of your programming effort is complete or even appropriate. Therefore, to be a successful programmer in the pharmaceutical industry, you need to understand validation requirements and to learn how to make the code do the bulk of the work so that your programs are efficient as well as accurate. This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration (FDA). Authors Carol Matthews and Brian Shilling provide practical examples, explanations for why different techniques are helpful, and tips for avoiding errors in your output. Topics addressed include: Validation and pharmaceutical industry overviews Documentation and maintenance requirements discussions General techniques to facilitate validation Data importing and exporting Common data types Reporting and statistics Validating Clinical Trial Data Reporting with SAS is designed for SAS programmers who are new to the pharmaceutical industry as well as for those seeking a good foundation for validation in the SAS programming arena. Readers should have a working knowledge of Base SAS and a basic understanding of programming tasks in the pharmaceutical industry.

Want to know what your users are thinking? If you're a product manager or developer, this book will help you learn the techniques for finding the answers to your most burning questions about your customers. With step-by-step guidance, Validating Product Ideas shows you how to tackle the research to build the best possible product.

Want to know what your users are thinking? If you're a product manager or developer, this book will help you learn the techniques for finding the answers to your most burning questions about your customers. With step-by-step guidance, Validating Product Ideas shows you how to tackle the research to build the best possible product.

This book critically examines the historical and philosophical foundations of construct validity theory (CVT), and how these have and continue to inform and constrain the conceptualization of validity and its application in research. CVT has had an immense impact on how researchers in the behavioural sciences conceptualize and approach their subject matter. Yet, there is equivocation regarding the foundations of the CVT framework as well as ambiguities concerning the nature of the “constructs” that are its raison d’etre. The book is organized in terms of three major parts that speak, respectively, to the historical, philosophical, and pragmatic dimensions of CVT. The primary objective is to provide researchers and students with a critical lens through which a deeper understanding may be gained of both the utility and limitations of CVT and the validation practices to which it has given rise. 

All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.

This book critically examines the historical and philosophical foundations of construct validity theory (CVT), and how these have and continue to inform and constrain the conceptualization of validity and its application in research. CVT has had an immense impact on how researchers in the behavioural sciences conceptualize and approach their subject matter. Yet, there is equivocation regarding the foundations of the CVT framework as well as ambiguities concerning the nature of the “constructs” that are its raison d’etre. The book is organized in terms of three major parts that speak, respectively, to the historical, philosophical, and pragmatic dimensions of CVT. The primary objective is to provide researchers and students with a critical lens through which a deeper understanding may be gained of both the utility and limitations of CVT and the validation practices to which it has given rise. 

All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.

This book is intended for anyone who is seriously interested in designing and validating multiple-choice test items that measure understanding and the application of knowledge and skills to complex situations, such as critical thinking and problem solving. The most comprehensive and authoritative book in its field, this edition has been extensively revised to include: *more information about writing items that match content standards; *more information about creating item pools and item banking; *a new set of item-writing rules (with examples) in chapter 5, as well as guidelines for other multiple-choice formats; *hundreds of examples including an expanded chapter 4 devoted to exemplary item formats and a new chapter 6 containing exemplary items (with author annotations); *a chapter on item generation (chapter 7) featuring item modeling and other procedures that speed up item development; and *a more extensive set of references to past and current work in the area of multiple-choice item writing and validation. This book will be of interest to anyone who develops test items for large-scale assessments, as well as teachers and graduate students who desire the most comprehensive and authoritative information on the design and validation of multiple-choice test items.

Book is in Used-Good condition. Pages and cover are clean and intact. Used items may not include supplementary materials such as CDs or access codes. May show signs of minor shelf wear and contain limited notes and highlighting. 1.05

Nordeen, who has worked for Boeing for a number of years, tells the story of the Harrier II aircraft, tracing its development from US Marine Corps air-ground team close air support concepts in the 20s, through the first Harrier's evolution during Vietnam and near cancellation during the Carter administration, and Harrier II's use in Iraq and Afghanistan. The narrative includes interviews with military commanders, pilots, engineers, production personnel, including some figures who opposed the development of the craft. Appendices contain a timeline, a list of Harrier II squadrons, a production history and color photographs. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com)

This book is intended for anyone who is seriously interested in designing and validating multiple-choice test items that measure understanding and the application of knowledge and skills to complex situations, such as critical thinking and problem solving. The most comprehensive and authoritative book in its field, this edition has been extensively revised to include: *more information about writing items that match content standards; *more information about creating item pools and item banking; *a new set of item-writing rules (with examples) in chapter 5, as well as guidelines for other multiple-choice formats; *hundreds of examples including an expanded chapter 4 devoted to exemplary item formats and a new chapter 6 containing exemplary items (with author annotations); *a chapter on item generation (chapter 7) featuring item modeling and other procedures that speed up item development; and *a more extensive set of references to past and current work in the area of multiple-choice item writing and validation. This book will be of interest to anyone who develops test items for large-scale assessments, as well as teachers and graduate students who desire the most comprehensive and authoritative information on the design and validation of multiple-choice test items.

A companion volume to "Electrogravitics Systems: Reports on a New Propulsion Methodology," this book delivers (1) the scientific validation from three different authorities; (2) the compelling public history of gravity research conducted by the aviation industry before it became 'unacknowledged' and (3) testimonials which eye-witnesses have provided. In total, this anthology attests to the validity of the Biefeld-Brown high voltage force effect. The book's Science Section includes a well-known "electrokinetic force" and how it works; the proposed ion mobility explanation; and how electricity and gravity may couple. The Historical Section contains seven articles about T.T. Brown, gravity research, etc. Also included are a Testimonial Section and Patent Section.

Many financial institutions around the world must prove minimum compliance to the Basel II Accord by 2015. For several banks, implementing internal risk rating systems (IRRS) is simply Basel II compliance. However, when carried out with a proper focus on bottom-line growth, this regulation has been shown to enhance a bank's risk-management practices and competitiveness in the market. Basel II Implementation is an invaluable guide that puts a potent combination of theory and real-world practice at your fingertips. Written by two of the most globally recognized and sought-after thought leaders in Basel II implementation, this how-to book maps out, step-by-step, implementable solutions that are both academically credible and practical, making them defendable to regulators and executable within the constraints of data, resources, and time. Organized to sequentially follow IRRS development under Basel II, each section of this go-to guide provides: An introduction to the Basel II concept A variety of techniques for reaching compliance, based on research conducted by the authors and supported by Standard & Poor's Corporate case examples that illustrate implementation in the real world To complement the holistic approach in Basel II Implementation, which offers end-to-end analysis of various credit risk problems, an accompanying CD-ROM features a wealth of useful spreadsheet templates that will facilitate the efficient and accurate execution of covered techniques. Stay ahead of the curve with the expert strategies and advice found in Basel II Implementation.

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Many financial institutions around the world must prove minimum compliance to the Basel II Accord by 2015. For several banks, implementing internal risk rating systems (IRRS) is simply Basel II compliance. However, when carried out with a proper focus on bottom-line growth, this regulation has been shown to enhance a bank's risk-management practices and competitiveness in the market. Basel II Implementation is an invaluable guide that puts a potent combination of theory and real-world practice at your fingertips. Written by two of the most globally recognized and sought-after thought leaders in Basel II implementation, this how-to book maps out, step-by-step, implementable solutions that are both academically credible and practical, making them defendable to regulators and executable within the constraints of data, resources, and time. Organized to sequentially follow IRRS development under Basel II, each section of this go-to guide provides: An introduction to the Basel II concept A variety of techniques for reaching compliance, based on research conducted by the authors and supported by Standard & Poor's Corporate case examples that illustrate implementation in the real world To complement the holistic approach in Basel II Implementation, which offers end-to-end analysis of various credit risk problems, an accompanying CD-ROM features a wealth of useful spreadsheet templates that will facilitate the efficient and accurate execution of covered techniques. Stay ahead of the curve with the expert strategies and advice found in Basel II Implementation.

This Signal Analyzer is a portable test tool that is able to analyze SD/HD/3G SDI and HDMI 2.0 test patterns in a full range of resolutions up to 4K@ 60Hz (4:4:4). The unit assists users in validating the capabilities and proper operation of their source devices. When used with the 500830 Signal Generator, a useful set of cable connectivity/quality tests, and device compatibility tests can be performed to help identify problems.The device is an exceptional tool at an attractive price for any AV engineer/developer, Integrator and installer. The Signal Analyzer is a portable device which can be used anytime you need it and anywhere, making it an invaluable tool. The unit supports an internal rechargeable Lithium-ion battery, allowing the device to be operated autonomously for up to 5 hours per charge.Applications:• Testing AV source devices• Testing AV transmission infrastructure

This Signal Generator is a portable test tool that is able to generate SD/HD/3G SDI and HDMI 2.0 test patterns in a full range of resolutions up to 4K@ 60Hz (4:4:4). The unit assists users in validating the capabilities and proper operation of their sink devices. The user may select from various test pattern, resolutions, refresh rates, color spaces and other related parameters. When used with the 500831 Signal Analyzer, a useful set of cable connectivity/quality tests, and device compatibility tests can be performed to help identify problems.The device is an exceptional tool at an attractive price for any AV engineer/developer, Integrator and installer. The Signal Generator is a portable device which can be used anytime you need it and anywhere, making it an invaluable tool. The unit supports an internal rechargeable Lithium-ion battery, allowing the device to be operated autonomously for up to 5 hours per charge.Applications:• Testing AV sink devices• Testing AV transmission infrastructure

The Book of Judith tells the story of a fictitious Jewish woman beheading the general of the most powerful imaginable army to free her people. The parabolic story was set as an example of how God will help the righteous. Judith's heroic action not only became a validating charter myth of Judaism itself but has also been appropriated by many Christian and secular groupings, and has been an inspiration for numerous literary texts and works of art. It continues to exercise its power over artists, authors and academics and is becoming a major field of research in its own right. The Sword of Judith is the first multidisciplinary collection of essays to discuss representations of Judith throughout the centuries. It transforms our understanding across a wide range of disciplines. The collection includes new archival source studies, the translation of unpublished manuscripts, the translation of texts unavailable in English, and Judith images and music.

The English language edition of the successful French publication. The Ichimoku Kinko Hyo trading indicator is an information-rich and extremely reliable tool that can be employed across all time frames. Once you have learned the subtleties of the method and understand its unique system of validating price movements, it will improve your trading. Trading with Ichimoku is a practical handbook explaining the different elements of the Ichimoku system of chart reading, from the description of each of its five lines to their interpretation within a wider process of trading analysis. You will rapidly conclude that even though there are only five lines to look at on Ichimoku charts, the information given is more than enough to achieve a detailed and broad view of market and what the price action reveals. Part 1 is devoted to the theoretical description of the various components making up Ichimoku. Part 2 explains how to trade with Ichimoku Kinko Hyo through several examples in various time frames. Part 3 introduces trading methods that combine classical trading tools with Ichimoku Kinko Hyo. Explanations and examples are illustrated throughout with detailed colour charts. Whether you are a beginner or an accomplished trader, you should add a knowledge of Ichimoku to your armoury to improve your analysis and your results. Reviews from French readers: "I highly recommend this book for anyone who wants to learn to use Ichimoku." "Clear explanations and especially great tips on how to trade." "Very informative book with clear and precise examples." "Good balance between the theory, analysis and trading."