Post Authorization Safety Studies of Medicinal Products

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


Read or download book entitled Post Authorization Safety Studies of Medicinal Products written by Ayad K. Ali which was release on 27 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 : 2018-06-27
  • Total pages : 362
  • ISBN : 0128092084
GET BOOK

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 : 0128092084
GET BOOK

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 : 0128092084
GET BOOK

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 ...

Pharmaceutical Practice

Pharmaceutical Practice
  • Author : Jennie Watson,Judith A Rees,Ian Smith
  • Publisher : Elsevier Health Sciences
  • Release Date : 2014-01-16
  • Total pages : 576
  • ISBN : 0128092084
GET BOOK

Summary : 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, ...

Pharmacoepidemiology

Pharmacoepidemiology
  • Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
  • Publisher : John Wiley & Sons
  • Release Date : 2019-10-23
  • Total pages : 1208
  • ISBN : 0128092084
GET BOOK

Summary : This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, ...

EU Law of Competition and Trade in the Pharmaceutical Sector

EU Law of Competition and Trade in the Pharmaceutical Sector
  • Author : Pablo Figueroa,Alejandro Guerrero
  • Publisher : Edward Elgar Publishing
  • Release Date : 2019
  • Total pages : 816
  • ISBN : 0128092084
GET BOOK

Summary : This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. ...

Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology
  • Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
  • Publisher : John Wiley & Sons
  • Release Date : 2022-01-18
  • Total pages : 560
  • ISBN : 0128092084
GET BOOK

Summary : Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies ...

Pharmaceutical Medicine

Pharmaceutical Medicine
  • Author : Adrian Kilcoyne,Phil Ambery,Daniel O'Connor
  • Publisher : OUP Oxford
  • Release Date : 2013-05-23
  • Total pages : 480
  • ISBN : 0128092084
GET BOOK

Summary : The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through ...

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
  • Author : Divya Vohora,Gursharan Singh
  • Publisher : Academic Press
  • Release Date : 2017-11-14
  • Total pages : 526
  • ISBN : 0128092084
GET BOOK

Summary : 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 ...

Stephens Detection and Evaluation of Adverse Drug Reactions

Stephens  Detection and Evaluation of Adverse Drug Reactions
  • Author : John Talbot,Jeffrey K. Aronson
  • Publisher : John Wiley & Sons
  • Release Date : 2011-10-28
  • Total pages : 648
  • ISBN : 0128092084
GET BOOK

Summary : The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal ...

Pharmacy Practice E Book

Pharmacy Practice E Book
  • Author : Jennie Watson,Louise Siobhan Cogan
  • Publisher : Elsevier Health Sciences
  • Release Date : 2019-07-24
  • Total pages : 496
  • ISBN : 0128092084
GET BOOK

Summary : The sixth edition of PharmacyPractice brings the contents completely up to date, reflecting 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 pharmaco-economics. Each chapter begins with ...

The Impact of Off Label Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries

The Impact of Off Label  Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries
  • Author : Vanessa Plate
  • Publisher : Columbia University Press
  • Release Date : 2010-07-01
  • Total pages : 174
  • ISBN : 0128092084
GET BOOK

Summary : In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use -- generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a ...

Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society
  • Author : Sven Stegemann
  • Publisher : Springer
  • Release Date : 2016-10-20
  • Total pages : 771
  • ISBN : 0128092084
GET BOOK

Summary : This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as ...

Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition

Cobert s Manual Of Drug Safety And Pharmacovigilance  Third Edition
  • Author : Cobert Barton,Gregory William,Thomas Jean-loup
  • Publisher : World Scientific
  • Release Date : 2019-04-10
  • Total pages : 524
  • ISBN : 0128092084
GET BOOK

Summary : Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and ...

2001 20 EC A European Directive

2001 20 EC   A European Directive
  • Author : Barbara Römer
  • Publisher : Tectum Wissenschaftsverlag
  • Release Date : 2011-11-01
  • Total pages : 186
  • ISBN : 0128092084
GET BOOK

Summary : Everybody who has performed multi-center clinical trials knows that it is a real challenge to prepare a clinical trial application in different European countries. Frequently asked questions are: Which documents should be included into the submission package? Which timelines apply for the Competent Authority and Ethics Committee evaluation procedure? Are ...