Post Authorization Safety Studies of Medicinal Products

Written By Ayad K. Ali
Post Authorization Safety Studies of Medicinal Products
  • Publsiher : Academic Press
  • Release : 01 June 2018
  • ISBN : 9780128092170
  • Pages : 512 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Post Authorization Safety Studies of Medicinal Products written by Ayad K. Ali which was release on 01 June 2018, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products
  • Author : Ayad K. Ali,Abraham G. Hartzema
  • Publisher : Academic Press
  • Release Date : 2018-06
  • Total pages : 512
  • ISBN : 9780128092170
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Summary : Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources ...

Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products
  • Author : Ayad K. Ali,Abraham G. Hartzema
  • Publisher : Academic Press
  • Release Date : 2018-06-27
  • Total pages : 362
  • ISBN : 9780128092170
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Summary : Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources ...

Mann s Pharmacovigilance

Mann s Pharmacovigilance
  • Author : Elizabeth B. Andrews,Nicholas Moore
  • Publisher : John Wiley & Sons
  • Release Date : 2014-03-24
  • Total pages : 872
  • ISBN : 9780128092170
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Summary : Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice ...

Vaccinology

Vaccinology
  • Author : Alan D. T. Barrett
  • Publisher : John Wiley & Sons
  • Release Date : 2015-02-16
  • Total pages : 400
  • ISBN : 9780128092170
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Summary : Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating ...

Veterinary Pharmacovigilance

Veterinary Pharmacovigilance
  • Author : Kevin Woodward
  • Publisher : John Wiley & Sons
  • Release Date : 2009-11-24
  • Total pages : 776
  • ISBN : 9780128092170
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Summary : Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise ...

Drug Safety Evaluation

Drug Safety Evaluation
  • Author : Shayne C. Gad
  • Publisher : Wiley-Interscience
  • Release Date : 2002-04-18
  • Total pages : 1007
  • ISBN : 9780128092170
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Summary : Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity....

Library Information Science Abstracts

Library   Information Science Abstracts
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2003
  • Total pages : 212
  • ISBN : 9780128092170
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Summary : Download or read online Library Information Science Abstracts written by , published by which was released on 2003. Get Library Information Science Abstracts Books now! Available in PDF, ePub and Kindle....

Principles of Clinical Research

Principles of Clinical Research
  • Author : Institute of Clinical Research
  • Publisher : Routledge
  • Release Date : 2001
  • Total pages : 558
  • ISBN : 9780128092170
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Summary : In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials....

The Rules Governing Medicinal Products in the European Community Guidelines on the quality safety and efficacy of medicinal products for human use

The Rules Governing Medicinal Products in the European Community  Guidelines on the quality  safety and efficacy of medicinal products for human use
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1989
  • Total pages : 212
  • ISBN : 9780128092170
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Summary : EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs....

Reports of Cases Before the Court

Reports of Cases Before the Court
  • Author : Court of Justice of the European Communities
  • Publisher : Unknown
  • Release Date : 2003
  • Total pages : 212
  • ISBN : 9780128092170
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Summary : Download or read online Reports of Cases Before the Court written by Court of Justice of the European Communities, published by which was released on 2003. Get Reports of Cases Before the Court Books now! Available in PDF, ePub and Kindle....

Pharmacovigilance Medical Writing

Pharmacovigilance Medical Writing
  • Author : Justina Orleans-Lindsay
  • Publisher : John Wiley & Sons
  • Release Date : 2012-06-22
  • Total pages : 288
  • ISBN : 9780128092170
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Summary : Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the ...

Pharmacovigilance

Pharmacovigilance
  • Author : Ronald D. Mann,Elizabeth B. Andrews
  • Publisher : John Wiley & Sons
  • Release Date : 2007-02-06
  • Total pages : 702
  • ISBN : 9780128092170
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Summary : Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, ...

Official Journal of the European Communities

Official Journal of the European Communities
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2000
  • Total pages : 212
  • ISBN : 9780128092170
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Summary : Download or read online Official Journal of the European Communities written by , published by which was released on 2000. Get Official Journal of the European Communities Books now! Available in PDF, ePub and Kindle....

The Rules Governing Medicinal Products in the European Community

The Rules Governing Medicinal Products in the European Community
  • Author : Commission of the European Communities
  • Publisher : Bernan Press(PA)
  • Release Date : 1993
  • Total pages : 217
  • ISBN : 9780128092170
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Summary : Download or read online The Rules Governing Medicinal Products in the European Community written by Commission of the European Communities, published by Bernan Press(PA) which was released on 1993. Get The Rules Governing Medicinal Products in the European Community Books now! Available in PDF, ePub and Kindle....

Safety Pharmacology in Pharmaceutical Development

Safety Pharmacology in Pharmaceutical Development
  • Author : Shayne C. Gad
  • Publisher : CRC Press
  • Release Date : 2012-04-26
  • Total pages : 213
  • ISBN : 9780128092170
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Summary : Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions. Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second ...