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Post Authorization Safety Studies Of Medicinal Products

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Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products Book
Author : Ayad K. Ali,Abraham G. Hartzema
Publisher : Academic Press
Release : 2018-06
ISBN : 9780128092170
Language : En, Es, Fr & De

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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

Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products Book
Author : Ayad K. Ali,Abraham G. Hartzema
Publisher : Academic Press
Release : 2018-06-27
ISBN : 0128092084
Language : En, Es, Fr & De

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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

Mann s Pharmacovigilance

Mann s Pharmacovigilance Book
Author : Elizabeth B. Andrews,Nicholas Moore
Publisher : John Wiley & Sons
Release : 2014-03-24
ISBN : 1118820142
Language : En, Es, Fr & De

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Book Description :

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, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Vaccinology

Vaccinology Book
Author : Alan D. T. Barrett
Publisher : John Wiley & Sons
Release : 2015-02-16
ISBN : 0470656166
Language : En, Es, Fr & De

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Book Description :

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 platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes. Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice.

Pharmaceutical Medicine

Pharmaceutical Medicine Book
Author : Adrian Kilcoyne,Phil Ambery,Daniel O'Connor
Publisher : OUP Oxford
Release : 2013-05-23
ISBN : 019101589X
Language : En, Es, Fr & De

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Book Description :

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 page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.

Pharmaceutical Practice

Pharmaceutical Practice Book
Author : Jennie Watson,Judith A Rees,Ian Smith
Publisher : Elsevier Health Sciences
Release : 2014-01-16
ISBN : 0702052825
Language : En, Es, Fr & De

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Book Description :

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 labeling of medicines, sterilization, prescriptions, hospital-based services, techniques and treatments, adverse drug reactions, cost-benefit, and medicines management. Each chapter begins with Study Point and ends with Key Points to reinforce learning. Appendices include medical abbreviations, Latin terms and abbreviations, systems of weights and measurements, presentation skills and key references. Self-assessment questions for more complex areas of pharmaceutical practice. New chapters on control of medicines; control of health professionals and their staff; ethics in practice; Standard Operating Procedures; structure and organisation of pharmacy; veterinary pharmacy; appliances; public health, and pharmacy interventions. New editor on the team, Jennie Watson. Many new contributors, comprising practising pharmacists, teachers of pharmacy, and pharmacists with joint appointments between hospital/community pharmacy and universities.

Pharmacoepidemiology

Pharmacoepidemiology Book
Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Release : 2019-10-23
ISBN : 1119413427
Language : En, Es, Fr & De

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Book Description :

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, applications and methodologies with great clarity.

EU Law of Competition and Trade in the Pharmaceutical Sector

EU Law of Competition and Trade in the Pharmaceutical Sector Book
Author : Pablo Figueroa,Alejandro Guerrero
Publisher : Edward Elgar Publishing
Release : 2019
ISBN : 1785362615
Language : En, Es, Fr & De

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Book Description :

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. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research Book
Author : Divya Vohora,Gursharan Singh
Publisher : Academic Press
Release : 2017-11-14
ISBN : 0128020989
Language : En, Es, Fr & De

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Book Description :

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 aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Stephens Detection and Evaluation of Adverse Drug Reactions

Stephens  Detection and Evaluation of Adverse Drug Reactions Book
Author : John Talbot,Jeffrey K. Aronson
Publisher : John Wiley & Sons
Release : 2011-12-19
ISBN : 0470986344
Language : En, Es, Fr & De

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Book Description :

Written with practitioners in mind, this new edition of Stephen’s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.

Pharmacy Practice E Book

Pharmacy Practice E Book Book
Author : Jennie Watson,Louise Siobhan Cogan
Publisher : Elsevier Health Sciences
Release : 2019-07-24
ISBN : 0702074284
Language : En, Es, Fr & De

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Book Description :

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 Study Points and ends with Key Points to reinforce learning. Appendices include medical abbreviations, Latin terms and abbreviations, systems of weights and measurements and presentation skills. Some chapters also carry self-assessment questions for more complex areas of pharmaceutical practice. New editor on the team, Louise Cogan. Many new contributors, comprising practising pharmacists, teachers of pharmacy, and pharmacists with joint appointments between hospital/community pharmacy and universities. Now with companion e-book included on StudentConsult New chapters on Consent History Taking/ Gathering Information Advice giving and the pharmacist as a Health Trainer Using calculations in pharmacy practice Continuing professional development and revalidation Intra and inter professional working, The role of the pharmacist in medicines optimization

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 Book
Author : Vanessa Plate
Publisher : Columbia University Press
Release : 2010-07-01
ISBN : 3838261356
Language : En, Es, Fr & De

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Book Description :

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 knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Platé gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.

Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society Book
Author : Sven Stegemann
Publisher : Springer
Release : 2016-10-20
ISBN : 3319430998
Language : En, Es, Fr & De

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Book Description :

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.

Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition

Cobert s Manual Of Drug Safety And Pharmacovigilance  Third Edition  Book
Author : Cobert Barton,Gregory William,Thomas Jean-loup
Publisher : World Scientific
Release : 2019-04-10
ISBN : 9813279168
Language : En, Es, Fr & De

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Book Description :

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 the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

2001 20 EC A European Directive

2001 20 EC   A European Directive  Book
Author : Barbara Römer
Publisher : Tectum Wissenschaftsverlag
Release : 2011-11-01
ISBN : 3828852084
Language : En, Es, Fr & De

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Book Description :

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 the Competent Authority and Ethics Committee procedures linked together or independent? Regarding the ten European Countries Austria, Belgium, Czech Republic, Germany, Italy, Slovenia, Spain, The Netherlands, Poland and UK your questions will be answered in this book. Beyond the answers to these questions short-, middle- and long-term measures are proposed in order to improve the harmonisation of the clinical trial authorisation procedures in the EU and finally to increase Europe's attractiveness for clinical research and to ensure global market competitiveness.

Veterinary Pharmacovigilance

Veterinary Pharmacovigilance Book
Author : Kevin Woodward
Publisher : John Wiley & Sons
Release : 2009-11-24
ISBN : 9781444322941
Language : En, Es, Fr & De

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Book Description :

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.

Essentials of Clinical Research

Essentials of Clinical Research Book
Author : Stephen P. Glasser
Publisher : Springer
Release : 2014-06-02
ISBN : 3319054708
Language : En, Es, Fr & De

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Book Description :

In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

European Union Health Law

European Union Health Law Book
Author : André den Exter,Tamara Hervey
Publisher : Maklu
Release : 2012
ISBN : 9046605442
Language : En, Es, Fr & De

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Book Description :

This volume contains EU-related health legislation relevant to legal training programs on EU law and healthcare. Despite the availability of numerous handbooks, a collection of EU legislation on health has been missing. The book includes relevant treaty law provisions and secondary legislation (abridged) on health or health-related norms, clustered as: EU treaty law * human rights and health * public health * patient safety * consumer protection * patient mobility * mobility of health professionals * pharmaceuticals * medical devices * data protection * insurance * competition law.

Rare Diseases Epidemiology Update and Overview

Rare Diseases Epidemiology  Update and Overview Book
Author : Manuel Posada de la Paz,Domenica Taruscio,Stephen C. Groft
Publisher : Springer
Release : 2017-12-06
ISBN : 3319671448
Language : En, Es, Fr & De

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Book Description :

The fields of rare diseases research and orphan products development continue to expand with more products in research and development status. In recent years, the role of the patient advocacy groups has evolved into a research partner with the academic research community and the bio-pharmaceutical industry. Unique approaches to research and development require epidemiological data not previously available to assist in protocol study design and patient recruitment for clinical trials required by regulatory agencies prior to approval for access by patents and practicing physicians.

Medical Product Safety Evaluation

Medical Product Safety Evaluation Book
Author : Jie Chen,Joseph Heyse,Tze Leung Lai
Publisher : CRC Press
Release : 2018-09-03
ISBN : 1351021966
Language : En, Es, Fr & De

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Book Description :

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.