• Home
  • Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance
  • Author : Sabrina Nour
  • Publsiher : Academic Press
  • Release : 17 October 2018
  • ISBN : 012816381X
  • Pages : 144 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKPharmacoepidemiology and Pharmacovigilance

Summary:
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 the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and 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


Understanding Pharmacoepidemiology

Understanding Pharmacoepidemiology
  • Author : Yi Yang,Donna West-Strum
  • Publisher : McGraw Hill Professional
  • Release : 31 December 2010
GET THIS BOOKUnderstanding Pharmacoepidemiology

A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have


Textbook of Pharmacoepidemiology

Textbook of Pharmacoepidemiology
  • Author : Brian L. Strom,Stephen E. Kimmel
  • Publisher : John Wiley & Sons
  • Release : 13 May 2013
GET THIS BOOKTextbook of Pharmacoepidemiology

The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public


Pharmacovigilance and Pharmacoepidemiology

Pharmacovigilance and Pharmacoepidemiology
  • Author : Ravi Humbarwadi
  • Publisher : CreateSpace
  • Release : 05 August 2014
GET THIS BOOKPharmacovigilance and Pharmacoepidemiology

Pharmacovigilance and Pharmacoepidemiology. MedDRA Coding, ICSR, Types of reports, Causality, SUSAR, EMEA, GVP, Eudravigilance, FDA, MedWATCH, Signal Detection, List of IME, and Narrative Writing. NIS (Non interventional study), PASS (Post authorisation safety study). Role of epidemiology in RMP (Risk Management Plan), CER (Competitive Efectiveness research), Post Marketing risk profile and Post marketing Signals. Cohort, Case control and study designs. EuPAS, Good Pharmacoepidemiology Practice (GPP), STROBE, EnCePP, Protocol and Guidelines.


An Introduction to Pharmacovigilance

An Introduction to Pharmacovigilance
  • Author : Patrick Waller,Mira Harrison-Woolrych
  • Publisher : John Wiley & Sons
  • Release : 01 May 2017
GET THIS BOOKAn Introduction to Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those


Mann's Pharmacovigilance

Mann's Pharmacovigilance
  • Author : Elizabeth B. Andrews,Nicholas Moore
  • Publisher : John Wiley & Sons
  • Release : 24 March 2014
GET THIS BOOKMann's Pharmacovigilance

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 of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis,



Drug Safety

Drug Safety
  • Author : Ravi Humbarwadi
  • Publisher : CreateSpace
  • Release : 16 April 2015
GET THIS BOOKDrug Safety

Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoepidemiology : Study Designs - Types designs and their use in different situations. Comprehensive description of NIS. Protocol, STROBE, ENCePP and Good pharmacoepidemiology Practices.Pharmacovigilance Database : Graphic Description. Field by Filed and Module by Module. Includes Overview of Oracle ARGUS.


Pharmacovigilance

Pharmacovigilance
  • Author : I. Ralph Edwards,Marie Lindquist
  • Publisher : Springer
  • Release : 27 October 2016
GET THIS BOOKPharmacovigilance

Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus


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


Pharmacoepidemiology

Pharmacoepidemiology
  • Author : Brian L. Strom
  • Publisher : John Wiley & Sons
  • Release : 04 January 2006
GET THIS BOOKPharmacoepidemiology

The fourth edition of Pharmacoepidemiology is an outstanding and fully comprehensive textbook, which will be an essential resource for all interested in the field—in academia, in regulatory agencies, in industry and in the law. Brian Strom’s classic textbook continues both to reflect the increased maturation of pharmacoepedemiology and to help shape it’s direction. Reviews of previous editions of his celebrated textbook include: "The book is essential reading for anyone interested in pharmacoepidemiology." INTERNATIONAL JOURNAL OF EPIDEMIOLOGY “...an



Pharmacovigilance

Pharmacovigilance
  • Author : Ronald D. Mann,Elizabeth B. Andrews
  • Publisher : John Wiley & Sons
  • Release : 24 January 2003
GET THIS BOOKPharmacovigilance

Interest in the field of pharmacovigilance has grown rapidly in recent years with the possible toxicity of a drug becoming as much a focus of clinical trials as its benefits. This key text is a definitive resource for professionals working within pharmacovigilance. Written by leading professionals in the field, its clear structure, covers all the important aspects of the subject including:- * Legal aspects * Drug regulatory requirements * Methods of signal generation * Reporting schemes * Pharmacovigilance in selected system-organ classes * Future directions


Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society
  • Author : Sven Stegemann
  • Publisher : Springer
  • Release : 20 October 2016
GET THIS BOOKDeveloping Drug Products in an Aging Society

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 Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.


Clinical Pharmacy Education, Practice and Research

Clinical Pharmacy Education, Practice and Research
  • Author : Dixon Thomas
  • Publisher : Elsevier
  • Release : 23 November 2018
GET THIS BOOKClinical Pharmacy Education, Practice and Research

Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a