Post Authorization Safety Studies of Medicinal Products

Book Post Authorization Safety Studies of Medicinal Products Cover

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  • Publisher : Academic Press
  • Release : 27 June 2018
  • ISBN : 9780128092088
  • Page : 362 pages
  • Rating : 4.5/5 from 103 voters

Post Authorization Safety Studies of Medicinal Products Book PDF 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

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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
  • ISBN : 9780128092088
DOWNLOAD 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

Mann's Pharmacovigilance

Mann's Pharmacovigilance
  • Author : Elizabeth B. Andrews,Nicholas Moore
  • Publisher : John Wiley & Sons
  • Release Date : 2014-03-24
  • ISBN : 9781118820148
DOWNLOAD 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,

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The Importance of Pharmacovigilance
  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2002-01-01
  • ISBN : 9241590157
DOWNLOAD BOOKThe Importance of Pharmacovigilance

The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.

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  • Author : Gregg N. Milligan,Alan D. T. Barrett
  • Publisher : John Wiley & Sons
  • Release Date : 2014-12-04
  • ISBN : 9781118636527
DOWNLOAD BOOKVaccinology

Vaccinology: An Essential Guide outlines in a clear,practical format the entire vaccine development process, fromconceptualization and basic immunological principles through toclinical testing and licensing of vaccines. With anoutstanding introduction to the history and practice ofvaccinology, it also guides the reader through the basic sciencerelating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economicand geographical issues that drive vaccine development and trials,it also presents vaccine delivery strategies, novel vaccineplatforms (including experimental vaccines and pathogens), antigendevelopment

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  • Author : Adrian Kilcoyne,Phil Ambery,Daniel O'Connor
  • Publisher : OUP Oxford
  • Release Date : 2013-05-23
  • ISBN : 9780191015892
DOWNLOAD BOOKPharmaceutical Medicine

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.

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  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher : Government Printing Office
  • Release Date : 2014-04-01
  • ISBN : 9781587634338
DOWNLOAD 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

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  • Author : Monique Elseviers,Björn Wettermark,Anna Birna Almarsdóttir,Morten Andersen,Ria Benko,Marion Bennie,Irene Eriksson,Brian Godman,Janet Krska,Elisabetta Poluzzi,Kstja Taxis,Vera Vlahovic-Palcevski,Robert Vander Stichele
  • Publisher : John Wiley & Sons
  • Release Date : 2016-05-31
  • ISBN : 9781118949788
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Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation

International Pharmaceutical Product Registration, Second Edition

International Pharmaceutical Product Registration, Second Edition
  • Author : Anthony C. Cartwright,Brian R. Matthews
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • ISBN : 9781420081831
DOWNLOAD BOOKInternational Pharmaceutical Product Registration, Second Edition

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic

Toxicokinetics

Toxicokinetics
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1995
  • ISBN : MINN:31951D013437920
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Pharmaceutical Practice

Pharmaceutical Practice
  • Author : Jennie Watson,Judith A Rees,Ian Smith
  • Publisher : Elsevier Health Sciences
  • Release Date : 2014-01-16
  • ISBN : 9780702052828
DOWNLOAD 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

Report of the technical consultation on innovative clinical trial designs for development of new TB treatments

Report of the technical consultation on innovative clinical trial designs for development of new TB treatments
  • Author : Anonim
  • Publisher : World Health Organization
  • Release Date : 2021-07-28
  • ISBN : 9789240030862
DOWNLOAD BOOKReport of the technical consultation on innovative clinical trial designs for development of new TB treatments

The Global Tuberculosis Programme of the World Health Organization (WHO) convened a virtual technical consultation on “Innovative Clinical Trial Designs for Development of New TB Treatments” on 5 days between 20 August and 13 October 2021. The main objective of the meeting was to establish evidence-based approaches to trial designs and use of data to inform policy guidance of new regimens for the treatment of TB with the view to accelerate future regimen development. The consultation brought together researchers, academics, technical partners, TB drugs

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  • Author : Markus Müller
  • Publisher : Springer
  • Release Date : 2016-03-15
  • ISBN : 9783319273471
DOWNLOAD BOOKClinical Pharmacology: Current Topics and Case Studies

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.

EU Law of Competition and Trade in the Pharmaceutical Sector

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  • Author : Pablo Figueroa,Alejandro Guerrero
  • Publisher : Edward Elgar Publishing
  • Release Date : 2019
  • ISBN : 9781785362613
DOWNLOAD BOOKEU Law of Competition and Trade in the Pharmaceutical Sector

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.

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  • Author : André den Exter,Tamara Hervey
  • Publisher : Maklu
  • Release Date : 2012
  • ISBN : 9789046605448
DOWNLOAD BOOKEuropean Union Health Law

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.

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  • Author : Steven Piantadosi
  • Publisher : Springer Nature
  • Release Date : 2022-08-15
  • ISBN : 9783319526362
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