Drug Safety
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Drug Safety Data
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Author : Michael J. Klepper
language : en
Publisher: Jones & Bartlett Learning
Release Date : 2010-10-25
Drug Safety Data written by Michael J. Klepper and has been published by Jones & Bartlett Learning this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-25 with Medical categories.
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)
Practical Drug Safety From A To Z
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Author : Barton Cobert
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2009-10-06
Practical Drug Safety From A To Z written by Barton Cobert and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-06 with Medical categories.
The Practical Drug Safety from A to Z is an alphabetical guide to drug safety monitoring (pharmacovigilance), covering literally, the "A to Z" of maintaining drug safety. Written by experts in the field, this book is a perfect to companion to the Manual of Drug Safety and Pharmacovigilance and an essential reference for pharmacists, pharmacologists, hospital administrators, medical liability lawyers, and others.
Drug Safety Evaluation
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2003-09-05
Drug Safety Evaluation written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-05 with Medical categories.
Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Drug Safety
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Author : United States. Congress. House. Committee on Government Operations
language : en
Publisher:
Release Date : 1964
Drug Safety written by United States. Congress. House. Committee on Government Operations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1964 with Drugs categories.
Drug Safety Evaluation
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2023-01-12
Drug Safety Evaluation written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-12 with Medical categories.
Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.
Improving Drug Safety A Joint Responsibility
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Author : Rolf Dinkel
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-03-07
Improving Drug Safety A Joint Responsibility written by Rolf Dinkel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-07 with Medical categories.
As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).
Cancer Drug Safety And Public Health Policy
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Author : Charles Bennett
language : en
Publisher: Springer Nature
Release Date : 2022-11-30
Cancer Drug Safety And Public Health Policy written by Charles Bennett and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-30 with Medical categories.
This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.
Quantitative Drug Safety And Benefit Risk Evaluation
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Author : William Wang
language : en
Publisher: CRC Press
Release Date : 2021-12-30
Quantitative Drug Safety And Benefit Risk Evaluation written by William Wang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-30 with Mathematics categories.
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Cobert S Manual Of Drug Safety And Pharmacovigilance
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Author : Barton Cobert
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2011-04
Cobert S Manual Of Drug Safety And Pharmacovigilance written by Barton Cobert and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04 with Medical categories.
Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions. The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.
The Future Of Drug Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-02-27
The Future Of Drug Safety written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-27 with Medical categories.
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.