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Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products
  • Author : Ayad K. Ali
  • Publsiher : Academic Press
  • Release : 27 June 2018
  • ISBN : 0128092084
  • Pages : 362 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKPost Authorization Safety Studies of Medicinal Products

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 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 : 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


Vaccinology

Vaccinology
  • Author : Alan D. T. Barrett
  • Publisher : John Wiley & Sons
  • Release : 16 February 2015
GET THIS BOOKVaccinology

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 to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine


Pharmaceutical Practice

Pharmaceutical Practice
  • Author : Jennie Watson,Judith A Rees,Ian Smith
  • Publisher : Elsevier Health Sciences
  • Release : 16 January 2014
GET THIS BOOKPharmaceutical Practice

The fifth edition of Pharmaceutical Practice has been totally overhauled and restructured to bring the contents completely up to date and to reflect emerging new roles for pharmacists both within the traditional employment areas of hospital and community pharmacy, as well as other developing roles supporting the public health agenda, governance, risk management, prescribing and pharmacoeconomics. It covers a wide range of subjects relevant to pharmacy practice, including communication skills, managing a business, quality assurance, dispensing, calculations, packaging, storage and


Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach
  • Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
  • Publisher : Elsevier Health Sciences
  • Release : 31 July 2018
GET THIS BOOKPharmacovigilance: A Practical Approach

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.


Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance
  • 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


Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
  • Author : Divya Vohora,Gursharan Singh
  • Publisher : Academic Press
  • Release : 14 November 2017
GET THIS BOOKPharmaceutical Medicine and Translational Clinical Research

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



The Future of Drug Safety

The Future of Drug Safety
  • Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
  • Publisher : National Academies Press
  • Release : 27 February 2007
GET THIS BOOKThe Future of Drug Safety

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


Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
  • 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


Veterinary Pharmacovigilance

Veterinary Pharmacovigilance
  • Author : Kevin Woodward
  • 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.


Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
  • Author : Rebecca Sheets
  • Publisher : Academic Press
  • Release : 13 December 2017
GET THIS BOOKFundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and


Science, Medicine, and Animals

Science, Medicine, and Animals
  • Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research
  • Publisher : National Academies Press
  • Release : 19 January 2006
GET THIS BOOKScience, Medicine, and Animals

Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher’s Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the


Drug Discovery and Development

Drug Discovery and Development
  • Author : Omboon Vallisuta,Suleiman Olimat
  • Publisher : BoD – Books on Demand
  • Release : 03 June 2015
GET THIS BOOKDrug Discovery and Development

It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against


Detection of New Adverse Drug Reactions

Detection of New Adverse Drug Reactions
  • Author : M. D. B. Stephens,J. C. C. Talbot,Philip Routledge
  • Publisher : Nature Publishing Group
  • Release : 03 March 1998
GET THIS BOOKDetection of New Adverse Drug Reactions

This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.


Benefit-Risk Assessment in Pharmaceutical Research and Development

Benefit-Risk Assessment in Pharmaceutical Research and Development
  • Author : Andreas Sashegyi,James Felli,Rebecca Noel
  • Publisher : CRC Press
  • Release : 27 November 2013
GET THIS BOOKBenefit-Risk Assessment in Pharmaceutical Research and Development

Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a