Databases For Pharmacoepidemiological Research

This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research. Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research. This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15 years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them.

Textbook of Pharmacoepidemiology, Second Edition, provides an introduction to pharmacoepidemiology and the data sources, methods and applications used in clinical research, the pharmaceutical industry and regulatory agencies. Drawing upon the fifth edition of the authoritative reference, Pharmacoepidemiology, this new edition covers the key learning requirements of the discipline. The textbook provides an introduction to pharmacoepidemiology, pharmacoepidemiological data sources, special issues in methodology, special applications and future developments in the field. Updated learning features such as case studies, key points and Suggested Further Reading are included throughout the text. Textbook of Pharmacoepidemiology is a practical educational resource for upper-level undergraduates, graduate students, post-doctoral fellows in schools of public health, pharmacy and medicine, and for everyone learning and working in pharmacoepidemiology.

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.

We are delighted to present the inaugural Frontiers in Pharmacology 'Women in Pharmacoepidemiology” series of article collections. This Research Topic is part of the Women in Pharmacology series. Other titles in the series are: Women in Obstetric and Pediatric Pharmacology: 2021 Women in Inflammation Pharmacology: 2021 Women in Integrative and Regenerative Pharmacology: 2021 Women in Pharmacology of Anti-Cancer Drugs: 2021 Women in Pharmacology of Infectious Diseases: 2021 Women in Drug Metabolism and Transport: 2021 Women in Cardiovascular and Smooth Muscle Pharmacology: 2021 Women in Inflammation Pharmacology: 2021 Women in Pharmacogenetics and Pharmacogenomics: 2021 Women in Neuropharmacology: 2021 Women in Drugs Outcomes Research and Policies: 2021 Women in Pharmacology of Ion Channels and Channelopathies: 2021 At present, according to UNESCO, less than 30% of researchers worldwide are women. Long-standing biases and gender stereotypes are discouraging girls and women away from science-related fields, and STEM research in particular. Science and gender equality are, however, essential to ensure sustainable development as highlighted by UNESCO. In order to change traditional mindsets, gender equality must be promoted, stereotypes defeated, and girls and women should be encouraged to pursue STEM careers. Therefore, Frontiers in Pharmacology is proud to offer this platform to promote the work of women scientists at different stages in their career, all over the world, and across all fields of Pharmacology. The work presented here highlights the diversity of research performed across the entire breadth of Pharmacoepidemiology research and presents advances in theory, experiment, and methodology with applications to compelling problems. For this Topic, we will be welcoming manuscripts covering: • Post-marketing observational studies on medications • Post-marketing studies in populations routinely excluded from clinical trials such as children, pregnant women, and elderlies • Observational studies on First Nations, racialized groups, and immigrant populations • Real-world evidence using large population-based administrative or clinical databases • Pharmacoepidemiologic real world evidence methodology • Novel pharmacoepidemiologic methodology such as artificial intelligence and deep learning models • Pharmacoeconomic studies

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 health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting

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.

This book trains the next generation of scientists representing different disciplines to leverage the data generated during routine patient care. It formulates a more complete lexicon of evidence-based recommendations and support shared, ethical decision making by doctors with their patients. Diagnostic and therapeutic technologies continue to evolve rapidly, and both individual practitioners and clinical teams face increasingly complex ethical decisions. Unfortunately, the current state of medical knowledge does not provide the guidance to make the majority of clinical decisions on the basis of evidence. The present research infrastructure is inefficient and frequently produces unreliable results that cannot be replicated. Even randomized controlled trials (RCTs), the traditional gold standards of the research reliability hierarchy, are not without limitations. They can be costly, labor intensive, and slow, and can return results that are seldom generalizable to every patient population. Furthermore, many pertinent but unresolved clinical and medical systems issues do not seem to have attracted the interest of the research enterprise, which has come to focus instead on cellular and molecular investigations and single-agent (e.g., a drug or device) effects. For clinicians, the end result is a bit of a “data desert” when it comes to making decisions. The new research infrastructure proposed in this book will help the medical profession to make ethically sound and well informed decisions for their patients.

The multinational context of pharmacoepidemiology, and the resulting increased number ofmulti-sources studies have generated concerns in relation with conflicting results and the question of the impact of methodological choices on study results. Increasing the confidence in the conclusions derived from these observational studies is a crucial issue, which is closely related to the robustness of the evidence produced. In this area, impact of drug exposure measurement and risk window might be crucial.Drug exposure is mostly characterized by discontinuous episodes, marked by changes in doses and presence of concomitant medications. Considering the pharmacokinetic and pharmacodynamics characteristics specific to each individual drug, the way in which the drug exposure is presented is of great importance. However, methods used for handling drug exposure episodes in electronic healthcare databases are varying widely according studies. However, the impact of these methods.