Principles of Safety Pharmacology

Principles of Safety Pharmacology
Author: Michael K. Pugsley
Publisher: Springer
Total Pages: 477
Release: 2015-06-19
Genre: Medical
ISBN: 366246943X

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Pharmacoepidemiology

Pharmacoepidemiology
Author: Brian L. Strom
Publisher: John Wiley & Sons
Total Pages: 1220
Release: 2019-12-16
Genre: Medical
ISBN: 1119413419

Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

Safety Pharmacology - Risk Assessment QT Interval Prolongation and Beyond

Safety Pharmacology - Risk Assessment QT Interval Prolongation and Beyond
Author: Esther Pueyo
Publisher: Frontiers Media SA
Total Pages: 385
Release: 2018-08-16
Genre:
ISBN: 2889455394

Current regulatory guidelines for cardiac safety utilize hERG block and QT interval prolongation as risk markers. This strategy has been successful at preventing harmful drugs from being marketed, but criticized for leading to early withdrawal of potentially safe drugs. Here we collected a series of articles presenting new technological and conceptual advances, including refinement of ex vivo and in vitro assays, screens and models, and in silico approaches reflecting the increasing effort that has been put forward by regulatory agencies, industry, and academia to try and address the need of a more accurate, mechanistically-based paradigm of proarrhythmic potential of drugs. This Research Topic is dedicated to the memory of Dr. J. Jeremy Rice, our wonderful friend and colleague.

To Err Is Human

To Err Is Human
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 312
Release: 2000-03-01
Genre: Medical
ISBN: 0309068371

Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine

Pathophysiology and Pharmacology in Nursing

Pathophysiology and Pharmacology in Nursing
Author: Sarah Ashelford
Publisher: Learning Matters
Total Pages: 441
Release: 2019-05-15
Genre: Medical
ISBN: 1526471388

Pathophysiology and Pharmacology in Nursing provides an integrated introduction to both the biology of disease and the therapeutic agents that are used to manage them.

Bad Pharma

Bad Pharma
Author: Ben Goldacre
Publisher: Macmillan
Total Pages: 479
Release: 2014-04
Genre: Business & Economics
ISBN: 0865478066

Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Drug Discovery and Evaluation: Methods in Clinical Pharmacology
Author: H.Gerhard Vogel
Publisher: Springer Science & Business Media
Total Pages: 576
Release: 2010-12-15
Genre: Medical
ISBN: 3540898905

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Targeted Therapies in Oncology, Second Edition

Targeted Therapies in Oncology, Second Edition
Author: Giuseppe Giaccone
Publisher: CRC Press
Total Pages: 500
Release: 2013-10-21
Genre: Medical
ISBN: 1842145452

Since the last edition of this book, major advances have been made in our understanding of key pathways that control tumor progression. This has led to the development of new anticancer agents that have the ability to block the activity of proteins involved in neoplastic cell development and proliferation. Targeted Therapies in Oncology, Second Edition provides a concise timely panorama of existing targeted therapies and progress into future anticancer treatments. These therapies notably include: Targeted agents of immune checkpoints Signal-transduction inhibitors Antiangiogenic agents Vascular-disrupting agents Apoptosis modulators Stem cell inhibitors Tumor profiling for drug development The book emphasizes the biology behind this new class of drugs as well as the clinical achievements obtained. The contributors to this volume stand at the cutting edge of cancer research and treatment around the world.

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology
Author: Mary Jeanne Kallman
Publisher: Academic Press
Total Pages: 362
Release: 2018-09-05
Genre: Medical
ISBN: 0128123346

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues. - Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice - Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more - Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs

Veterinary Pharmacology and Therapeutics

Veterinary Pharmacology and Therapeutics
Author: Jim E. Riviere
Publisher: John Wiley & Sons
Total Pages: 3248
Release: 2017-12-13
Genre: Medical
ISBN: 1118855884

Veterinary Pharmacology and Therapeutics, Tenth Edition is a fully updated and revised version of the gold-standard reference on the use of drug therapy in all major veterinary species. Provides current, detailed information on using drug therapies in all major domestic animal species Organized logically by drug class and treatment indication, with exhaustive information on the rational use of drugs in veterinary medicine Includes extensive tables of pharmacokinetic data, products available, and dosage regimens Adds new chapters on pharmaceutics, ophthalmic pharmacology, food animal pharmacology, and aquatic animal pharmacology Includes access to a companion website with the figures from the book in PowerPoint