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Author: Michael J. Klepper Publisher: Jones & Bartlett Publishers ISBN: 1449671551 Category : Medical Languages : en Pages : 332
Book Description
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Author: Michael J. Klepper Publisher: Jones & Bartlett Publishers ISBN: 1449671551 Category : Medical Languages : en Pages : 332
Book Description
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Author: Stephen Haag Publisher: Irwin/McGraw-Hill ISBN: 9780073105819 Category : Business & Economics Languages : en Pages : 0
Book Description
A concise, four-color IS concepts book with a lively, contemporary writing style at a student-friendly price. Information Systems Essentials Information Systems Essentials comes with more and better ancillaries than any other essentials text.An additional unique feature is the opening unit, explaining the benefit and impact of IS on each business career. This chapter addresses the frequently-cited problem of effectively showing students the relevance of this course.Information Systems Essentials includes the first nine chapters from Haag MIS 5e, representing what introductory MIS students should definitely know. An appendix includes the two XLMs from Haag MIS 5e: hardware/software and telecommunications.
Author: Patrick Lee Miller Publisher: Hackett Publishing ISBN: 1624663540 Category : Philosophy Languages : en Pages : 533
Book Description
This concise anthology of primary sources designed for use in an ancient philosophy survey ranges from the Presocratics to Plato, Aristotle, the Hellenistic philosophers, and the Neoplatonists. The Second Edition features an amplified selection of Presocratic fragments in newly revised translations by Richard D. McKirahan. Also included is an expansion of the Hellenistic unit, featuring new selections from Lucretius and Sextus Empiricus as well as a new translation, by Peter J. Anderson, of most of Seneca’s De Providentia. The selections from Plotinus have also been expanded.
Author: Ulric J. Gelinas Publisher: Cengage Learning ISBN: 9781133935940 Category : Business & Economics Languages : en Pages : 744
Book Description
Owners and managers rely on today's accounting professional to identify and monitor enterprise risks and to provide quality assurance for a company's information systems. ACCOUNTING INFORMATION SYSTEMS, 10E focuses on three critical accounting information systems in use today: enterprise systems, e-Business systems, and controls for maintaining those systems. The text fully explores the integrated nature of AIS with its foundations in information technology, business processes, strategic management, security, and internal controls. Students will easily grasp even the most challenging subjects as they explore today's most intriguing AIS topics discussed in a conversational and relaxed tone rather than complex technical language. The tenth edition provides students with the necessary tools for organizing and managing information to help them succeed and protect the integrity of their employer's information system. Important Notice: Media content referenced within the product description or the product text may not be available in the ebook version.
Author: Plato Publisher: Hackett Publishing ISBN: 1603849165 Category : Philosophy Languages : en Pages : 587
Book Description
A Plato Reader offers eight of Plato's best-known works--Euthyphro, Apology, Crito, Meno, Phaedo, Symposium, Phaedrus, and Republic--unabridged, expertly introduced and annotated, and in widely admired translations by C. D. C. Reeve, G. M. A. Grube, Alexander Nehamas, and Paul Woodruff. The collection features Socrates as its central character and a model of the examined life. Its range allows us to see him in action in very different settings and philosophical modes: from the elenctic Socrates of the Meno and the dialogues concerning his trial and death, to the erotic Socrates of the Symposium and Phaedrus, to the dialectician of the Republic. Of Reeve's translation of this final masterpiece, Lloyd P. Gerson writes, "Taking full advantage of S. R. Slings' new Greek text of the Republic, Reeve has given us a translation both accurate and limpid. Loving attention to detail and deep familiarity with Plato's thought are evident on every page. Reeve's brilliant decision to cast the dialogue into direct speech produces a compelling impression of immediacy unmatched by other English translations currently available."
Author: J. C. McKeown Publisher: Hackett Publishing ISBN: 9780872208513 Category : Foreign Language Study Languages : en Pages : 421
Book Description
Extensively field-tested and fine-tuned over many years, and designed specifically for a one-year course, JC McKeown's Classical Latin: An Introductory Course offers a thorough, fascinating, and playful grounding in Latin that combines the traditional grammatical method with the reading approach. In addition to grammar, paradigms, and readings, each chapter includes a variety of extraordinarily well-crafted exercises that reinforce the grammar and morphology while encouraging the joy of linguistic and cultural discovery.
Author: Barbara McNurlin Publisher: ISBN: 9781292023540 Category : Information resources management Languages : en Pages : 506
Book Description
The authors utilize their years of working with companies on IT management / strategy to provide students with a practical look at the evolution of IT in business. The use of examples that highlight what the real world has in store. Over 80 cases are featured throughout its entirety, so students can see how real companies have used IT in the past, the present, and how they may use IT in the future. IT is changing so rapidly that it is difficult time staying current. This text includes the most recent information and statistics. Two major developments that have been added are: The concept of mobile computing for on-demand, real-time needs and Changes in the business world itself such as, international trade, national and global security, Cybercrime, outsourcing and off-shoring, corporate malfeasance, terrorism, and regional conflicts. This book also provides students with an historical walkthrough of IT management to see how the use of IT has evolved in business. The lessons learned in the text can be applied to future jobs opportunities. This text works well in an EMBA program or a graduate class where many of the students are also working professionals, as well as providing a reference for students after they graduate.
Author: Thomas Aquinas Publisher: Hackett Publishing ISBN: 1603844449 Category : Philosophy Languages : en Pages : 426
Book Description
The third volume of The Hackett Aquinas, a series of central philosophical treatises of Aquinas in new, state-of-the-art translations accompanied by a thorough commentary on the text.
Author: Arthur Hyman Publisher: Hackett Publishing Company Incorporated ISBN: 9780915145805 Category : Philosophy Languages : en Pages : 805
Book Description
Contents: Early Mediaeval Christian Philosophy. Augustine, Boethius, John Scotus Eriugena, Anselm of Canterbury, Peter Abailard and John of Salisbury. Islamic Philosophy. Alfarabi, Avicenna, Algazali, Averroes. Jewish Philosophy. Saddia, Solomon Ibn Gabirol, Moses Maimonides, Levi Ben Gerson (Gersonides), Hasdai Crescas. Latin Philosophy in the Thirteenth Century. Bonaventure, Robert Grosseteste and Roger Bacon, Siger of Brabant, Thomas Aquinas, the Condemnation of 1277. Latin Philosophy in the Fourteenth Century. John Duns Scotus, William of Ockham, Nicholas of Autrecourt, Marsilius of Padua, John Buridan. Selected Bibliography. Index.
Author: Barbara Canning McNurlin Publisher: Prentice Hall ISBN: Category : Business & Economics Languages : en Pages : 680
Book Description
Dealing with the management of information technology (IT) as it is being practiced in organizations today, the emphasis of this book is on the current material that information systems executives find important; its organization is around a framework that readers new to the information can understand. In this 7 th edition, discussions include the rising societal risks of IT, new sections on digital convergence, messaging, and instant messaging, and a revised discussion on wireless technology. The topics of outsourcing and and information security have been updated and enhanced. Information Systems Management in Practicecontinues to merge theory with practice through real-world case examples. Topics include leadership issues, the CIO's responsibilities, uses of IT, information systems planning, essential technologies, managing operations, systems development, decision-making, collaboration, and knowledge work. An excellent reference resource for anyone employed in the information technology sector of business, especially managers of and executives in those departments.
Author: Michael J. Klepper
Author: Michael J. Klepper
Author: Stephen Haag
Author: Patrick Lee Miller
Author: Ulric J. Gelinas
Author: Plato
Author: J. C. McKeown
Author: Barbara McNurlin
Author: Thomas Aquinas
Author: Arthur Hyman
Author: Barbara Canning McNurlin