Post Authorization Safety Studies of Medicinal Products

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

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  • Author : Ayad K. Ali
  • Publisher : Academic Press
  • Pages : 362 pages
  • ISBN : 0128092084
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKPost Authorization Safety Studies of Medicinal Products

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 : 27 June 2018
GET THIS BOOKPost-Authorization Safety Studies of Medicinal Products

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

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  • Publisher : Edward Elgar Publishing
  • Release : 06 May 2021
GET THIS BOOKEU Law of Competition and Trade in the Pharmaceutical Sector

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  • Publisher : Academic Press
  • Release : 14 November 2017
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Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these

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  • Publisher : John Wiley & Sons
  • Release : 16 February 2015
GET THIS BOOKVaccinology

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  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher : Government Printing Office
  • Release : 01 April 2014
GET THIS BOOKRegistries for Evaluating Patient Outcomes

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database

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  • Author : Sabrina Nour,Gilles Plourde
  • Publisher : Academic Press
  • Release : 17 October 2018
GET THIS BOOKPharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate

Safety Pharmacology in Pharmaceutical Development

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  • Author : Shayne C. Gad
  • Publisher : CRC Press
  • Release : 26 April 2012
GET THIS BOOKSafety Pharmacology in Pharmaceutical Development

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 Su

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  • Publisher : Elsevier
  • Release : 16 April 2014
GET THIS BOOKTherapeutic Risk Management of Medicines

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have

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  • Author : Robin J. Harman
  • Publisher : Unknown Publisher
  • Release : 06 May 2021
GET THIS BOOKDevelopment and Control of Medicines and Medical Devices

This new title describes the tests and processes undertaken to bring new medicines and medical devices to the market, and the work of the government agencies which ensure products of the highest standard. The text covers the controls to prove quality, safety, and efficacy prior to marketing, and postmarketing pharmacovigilance requirements. The different European registration processes for both medicines and medical devices are explained. Important ethical issues in their development are also reviewed. The role of the UK and pan-European

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  • Publisher : Oxford University Press, USA
  • Release : 11 June 2015
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Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in "field trials", which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial design and conduct are

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  • Publisher : John Wiley & Sons
  • Release : 24 November 2009
GET THIS BOOKVeterinary Pharmacovigilance

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 of authors from around the world.