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Author: Michael J. Klepper
Publisher: Jones & Bartlett Publishers
ISBN: 1449671551
Category : Medical
Languages : en
Pages : 332
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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
Get Book Here
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: Lillian L. Randolph
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 504
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Book Description
The same principles behind arbitration of industrial and other disputes might also be applied to disputes between nations.
Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
ISBN: 9781727572667
Category :
Languages : en
Pages : 412
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Book Description
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section
Author: Jimmie C. Holland
Publisher: Oxford University Press
ISBN: 0199361487
Category : Medical
Languages : en
Pages : 240
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Book Description
Geriatric Psycho-Oncology is a comprehensive handbook that provides best practice models for the management of psychological, cognitive, and social outcomes of older adults living with cancer and their families. Chapters cover a wide range of topics including screening tools and interventions, psychiatric emergencies and disorders, physical symptom management, communication issues, and issues specific to common cancer sites. A resource section is appended to provide information on national services and programs. This book features contributions from experts designed to help clinicians review, anticipate and respond to emotional issues that often arise in the context of treating older cancer patients. Numerous cross-references and succinct tables and figures make this concise reference easy to use. Geriatric Psycho-Oncology is an ideal resource for helping oncologists and nurses recognize when it may be best to refer patients to their mental health colleagues and for those who are establishing or adding psychosocial components to existing clinics.
Author:
Publisher:
ISBN:
Category : Drug abuse and crime
Languages : en
Pages : 4
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Book Description
Author: U.s. Food and Drug Administration
Publisher: Createspace Independent Pub
ISBN: 9781500422288
Category : Health & Fitness
Languages : en
Pages : 34
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Book Description
What you eat and drink can affect the way your medicines work. Use this guide to alert you to possible "food-drug interactions" and to help you learn what you can do to prevent them. In this guide, a food-drug interaction is a change in how a medicine works caused by food, caffeine, or alcohol. A food-drug interaction can: prevent a medicine from working the way it should cause a side effect from a medicine to get worse or better cause a new side effect A medicine can also change the way your body uses a food. Any of these changes can be harmful. This guide covers interactions between some common prescription and over-the counter medicines and food, caffeine, and alcohol. These interactions come from medicine labels that FDA has approved. This guide uses the generic names of medicines, never brand names.
Author: John E. Cooney
Publisher: Simon & Schuster
ISBN:
Category : Biography & Autobiography
Languages : en
Pages : 456
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Book Description
"This is the colorful and dramatic biography of two of America's most controversial entrepreneurs: Moses Louis Annenberg, 'the racing wire king, ' who built his fortune in racketeering, invested it in publishing, and lost much of it in the biggest tax evasion case in United States history; and his son, Walter, launcher of TV Guide and Seventeen magazines and former ambassador to Great Britain."--Jacket.
Author: Enrico Dal Lago
Publisher: Cambridge University Press
ISBN: 1107038421
Category : History
Languages : en
Pages : 481
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Book Description
The first book that compares the Confederate South and Southern Italy in two contemporaneous civil wars during 1861-1865.
Author: John Ernest
Publisher: Government Institutes
ISBN: 1566639174
Category : History
Languages : en
Pages : 229
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Book Description
John Ernest offers a comprehensive survey of the broad-ranging and influential African American organizations and networks formed in the North in the late eighteenth century through the end of the Civil War. He examines fraternal organizations, churches, conventions, mutual aid benefit and literary societies, educational organizations, newspapers, and magazines. Ernest argues these organizations demonstrate how African Americans self-definition was not solely determined by slavery as they tried to create organizations in the hope of creating a community.
Author: Avrohom Pam
Publisher:
ISBN:
Category : Religion
Languages : en
Pages : 136
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Book Description
Torah thoughts based on and adapted from the teaching of Rabbi Abraham Pam.
