EudraLex: C: efficacy PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download EudraLex: C: efficacy PDF full book. Access full book title EudraLex: C: efficacy by . Download full books in PDF and EPUB format.
Author:
Publisher:
ISBN: 9789282824399
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author:
Publisher:
ISBN: 9789282824399
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: Ayad K. Ali
Publisher: Academic Press
ISBN: 0128092084
Category : Medical
Languages : en
Pages : 364
Get Book Here
Book Description
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
Author: Markus Müller
Publisher: Springer
ISBN: 3319273477
Category : Medical
Languages : en
Pages : 398
Get Book Here
Book Description
This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264805907
Category :
Languages : en
Pages : 447
Get Book Here
Book Description
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Author:
Publisher:
ISBN:
Category : European Union
Languages : en
Pages : 180
Get Book Here
Book Description
Author: A A Van Dooren
Publisher: World Scientific
ISBN: 9813223197
Category : Medical
Languages : en
Pages : 535
Get Book Here
Book Description
Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged.This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research.Related Link(s)
Author: Sumantra Ray
Publisher: Oxford University Press
ISBN: 0199608474
Category : Medical
Languages : en
Pages : 603
Get Book Here
Book Description
This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 24
Get Book Here
Book Description
Author: John Talbot
Publisher: John Wiley & Sons
ISBN: 1119952107
Category : Medical
Languages : en
Pages : 751
Get Book Here
Book Description
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 products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal
Author: Thao Doan
Publisher: Elsevier Health Sciences
ISBN: 032358117X
Category : Medical
Languages : en
Pages : 229
Get Book Here
Book Description
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. - Covers the evolving regulatory landscape, as well as current and future use of digital technologies. - Uses case studies to ensure content is relevant to everyday practice. - Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. - Consolidates today's available information on this timely topic into one convenient resource.
