Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products
Author: Ayad K. Ali,Abraham G. Hartzema
Publsiher: Academic Press
Total Pages: 362
Release: 2018-06-27
Genre: Medical
ISBN: 9780128092088

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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
Author: Elizabeth B. Andrews,Nicholas Moore
Publsiher: John Wiley & Sons
Total Pages: 872
Release: 2014-03-24
Genre: Medical
ISBN: 9781118820148

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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.

The Importance of Pharmacovigilance

The Importance of Pharmacovigilance
Author: World Health Organization
Publsiher: Unknown
Total Pages: 48
Release: 2002-01-01
Genre: Drug monitoring
ISBN: 9241590157

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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.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publsiher: Government Printing Office
Total Pages: 356
Release: 2014-04-01
Genre: Medical
ISBN: 9781587634338

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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 is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Drug Utilization Research

Drug Utilization Research
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
Publsiher: John Wiley & Sons
Total Pages: 536
Release: 2016-05-31
Genre: Medical
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 of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

Toxicokinetics

Toxicokinetics
Author: Anonim
Publsiher: Unknown
Total Pages: 16
Release: 1995
Genre: Government publications
ISBN: MINN:31951D013437920

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Vaccinology

Vaccinology
Author: Gregg N. Milligan,Alan D. T. Barrett
Publsiher: John Wiley & Sons
Total Pages: 400
Release: 2014-12-04
Genre: Medical
ISBN: 9781118636527

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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 and selection, vaccine modelling, and the developmentof vaccines against emerging pathogens and agents of bioterror.There are also sections devoted to veterinary vaccines andassociated regulatory processes. Vaccinology: An Essential Guide is a perfect tool fordesigned for undergraduate and graduate microbiologists andimmunologists, as well as residents, fellows and trainees ofinfectious disease and vaccinology. It is also suitable for allthose involved in designing and conducting clinical vaccine trials,and is the ideal companion to the larger reference bookVaccinology: Principles and Practice.

Pharmaceutical Medicine

Pharmaceutical Medicine
Author: Adrian Kilcoyne,Phil Ambery,Daniel O'Connor
Publsiher: OUP Oxford
Total Pages: 480
Release: 2013-05-23
Genre: Medical
ISBN: 9780191015892

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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.

International Pharmaceutical Product Registration Second Edition

International Pharmaceutical Product Registration  Second Edition
Author: Anthony C. Cartwright,Brian R. Matthews
Publsiher: CRC Press
Total Pages: 852
Release: 2016-04-19
Genre: Medical
ISBN: 9781420081831

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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 version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

Pharmaceutical Practice

Pharmaceutical Practice
Author: Jennie Watson,Judith A Rees,Ian Smith
Publsiher: Elsevier Health Sciences
Total Pages: 576
Release: 2014-01-16
Genre: Medical
ISBN: 9780702052828

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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.

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
Publsiher: World Health Organization
Total Pages: 135
Release: 2021-07-28
Genre: Medical
ISBN: 9789240030862

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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 and regimens developers including pharmaceutical industry, trialists, regulators, guideline developers, programme managers, nongovernmental organizations and civil society.

Clinical Pharmacology Current Topics and Case Studies

Clinical Pharmacology  Current Topics and Case Studies
Author: Markus Müller
Publsiher: Springer
Total Pages: 405
Release: 2016-03-15
Genre: Medical
ISBN: 9783319273471

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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

EU Law of Competition and Trade in the Pharmaceutical Sector
Author: Pablo Figueroa,Alejandro Guerrero
Publsiher: Edward Elgar Publishing
Total Pages: 816
Release: 2019
Genre: LAW
ISBN: 9781785362613

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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.

European Union Health Law

European Union Health Law
Author: André den Exter,Tamara Hervey
Publsiher: Maklu
Total Pages: 606
Release: 2012
Genre: Law
ISBN: 9789046605448

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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.

Practical Approaches to Risk Minimisation for Medicinal Products

Practical Approaches to Risk Minimisation for Medicinal Products
Author: World Health Organization
Publsiher: Unknown
Total Pages: 184
Release: 2015-03-02
Genre: Medical
ISBN: 9290360844

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Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.