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Safety Pharmacology
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Book Synopsis Advanced Issue Resolution in Safety Pharmacology by : Mary Jeanne Kallman
Download or read book Advanced Issue Resolution in Safety Pharmacology written by Mary Jeanne Kallman and published by Academic Press. This book was released on 2018-09-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley
Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Advanced Issue Resolution in Safety Pharmacology by : Mary Jeanne Kallman
Download or read book Advanced Issue Resolution in Safety Pharmacology written by Mary Jeanne Kallman and published by Academic Press. This book was released on 2018-09-05 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Understanding Pharmacology - E-Book by : M. Linda Workman
Download or read book Understanding Pharmacology - E-Book written by M. Linda Workman and published by Elsevier Health Sciences. This book was released on 2015-10-29 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacology can be difficult. But with the right text, understanding drugs and how they work doesn’t have to be! Using easy-to-follow language and engaging learning tools — like Memory Joggers, Clinical Pitfalls, Do Not Confuse, and Drug Alerts — the second edition of Understanding Pharmacology: Essentials for Medication Safety helps readers really understand how drugs work. In addition to the popular critical thinking activities from the first edition, the second edition also includes more chapter review questions, updated content, and a new organization that centers on the different body systems. For students who have a limited background in the sciences and want complete preparation for licensure exams and clinical practice, there is no better choice than Understanding Pharmacology, 2nd Edition! Entire unit reviewing math, weights and measures, and dosage calculation minimizes readers’ anxiety and promotes medication safety. Clever, easy-to-recognize margin icons help visual learners remember essential side effects of drugs. Simplified heading structure replaces intimidating terminology (i.e. pharmacokinetics) with simplified language (How These Drugs Work) to increase understanding of concepts. Drug Alert!, Do-Not-Confuse, and Clinical Pitfall boxes highlight important tips for safe medication administration. Memory Jogger boxes help readers remember important drug information. Get Ready for Practice sections at the end of each chapter include key points, chapter review questions, and critical thinking activities to reinforce learning. 10th grade reading level uses straightforward, everyday language to really enhance readers’ understanding of pharmacology concepts. Incorporation of adult learning theory features both a simple to complex organization of material along with answers to why readers need to learn something. NEW! Body system organization helps readers better understand drugs that are specific to particular body systems. NEW! More chapter review questions have been added to the text. All review questions are now organized into one of two categories: Test Yourself on the Basics and Test Yourself on Advanced Concepts.
Book Synopsis Safety Pharmacology in Pharmaceutical Development by : Shayne C. Gad
Download or read book Safety Pharmacology in Pharmaceutical Development written by Shayne C. Gad and published by CRC Press. This book was released on 2012-04-26 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions. Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.
Book Synopsis Safety Pharmacology in Pharmaceutical Development and Approval by : Shayne C. Gad
Download or read book Safety Pharmacology in Pharmaceutical Development and Approval written by Shayne C. Gad and published by CRC Press. This book was released on 2003-08-26 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Con
Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2003-09-05 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Book Synopsis Safety Pharmacology by : Atlas Holmes
Download or read book Safety Pharmacology written by Atlas Holmes and published by American Medical Publishers. This book was released on 2023-09-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety pharmacology deals with the detection and analysis of the potential adverse pharmacodynamic and pharmacological effects of new chemical entities (NCEs) on physiological processes, apart from the desired therapeutic effects. Such adverse effects of NCEs can be dangerous, especially in people who have damaged or reduced organ system functions. Safety pharmacology is vital throughout the process of drug discovery and development. There are three main goals of non-clinical safety pharmacology evaluations. First goal is to protect phase I clinical trial volunteers from acute drug side effects; second goal is to protect patients (including patients in phase II and III clinical trials), and last goal is to reduce the risk of failure during drug development and post-marketing phase due to undesirable pharmacodynamic effects. It is a fast-growing area of study in pharmacology and requires regulatory guidance. This book is a valuable compilation of topics, ranging from the basic to the most complex advancements in safety pharmacology. It explores all the important aspects of this field in the present day scenario. This book will serve as a valuable reference source for students and researchers.
Book Synopsis Safety Pharmacology - Risk Assessment QT Interval Prolongation and Beyond by : Esther Pueyo
Download or read book Safety Pharmacology - Risk Assessment QT Interval Prolongation and Beyond written by Esther Pueyo and published by Frontiers Media SA. This book was released on 2018-08-16 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis A Pharmacology Primer by : Terry Kenakin
Download or read book A Pharmacology Primer written by Terry Kenakin and published by Academic Press. This book was released on 2018-10-26 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery, Fifth Edition features the latest ideas and research regarding the application of pharmacology to the process of drug discovery. Written by well-respected pharmacologist, Terry P. Kenakin, this primer is an indispensable resource for all those involved in drug discovery. This updated edition has been thoroughly revised to include material on quantifying drug efficacy through bias and cluster analysis, the impact of molecular dynamics and protein structural analysis, the real time kinetic analysis of drug effect, virtual screening for new drug chemical scaffolds, and much more. With full color illustrations and new examples throughout, this book remains a top reference for all industry and academic scientists that is also ideal for students directly involved in drug discovery or pharmacologic research. Highlights changes surrounding strategies for drug discovery, providing a comprehensive reference and featuring advances in the methods involved Includes multiple new sections, such as development and utilization of models in pharmacology, de-orphanization of new drug targets, predicting impact of disease on drug pharmacokinetics, and the impact of enzyme kinetics on drug-drug interactions Illustrates the application of rapid inexpensive assays to predict activity in the therapeutic setting, showing data outcomes and the limitations inherent in interpreting this data
Book Synopsis Safety Evaluation of Pharmaceuticals and Medical Devices by : Shayne C. Gad
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Book Synopsis A Comprehensive Guide to Toxicology in Nonclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Elsevier. This book was released on 2024-02-11 with total page 1074 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Book Synopsis Safety Pharmacology by : Y. James Kang
Download or read book Safety Pharmacology written by Y. James Kang and published by . This book was released on 2006-12-01 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2023-01-12 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.
Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-12-01 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Book Synopsis Drug Safety Data by : Michael J. Klepper
Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2010-10-25 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
Book Synopsis Quality and Safety in Pharmacy Practice by : Terri L. Warholak
Download or read book Quality and Safety in Pharmacy Practice written by Terri L. Warholak and published by McGraw Hill Professional. This book was released on 2010-05-01 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gain a complete understanding of the principles of quality improvement and their application to present and future pharmacy practice "This book is a great resource for pharmacists and pharmacy students who want to learn about safety and quality in pharmacy practice."--Laura Cranston, RPh, Executive Director, The Pharmacy Quality Alliance Quality and Safety in Pharmacy Practice details the principles, approaches, strategies, and actions necessary to improve the overall safety and effectiveness of pharmacy services. Although one of the book’s primary goals is to enhance the quality of future health care, you will find guidelines that can be implemented immediately to improve today’s pharmacy practice. This comprehensive text offers a complete overview of quality in general, the reasons for improving practice, and actual day-to-day changes and approaches that will positively impact the patient. Quality and Safety in Pharmacy Practice is divided into five parts, covering: The current and future landscape of health care quality and the business case for quality improvement and value-driven health care Quality improvement concepts and tools, including statistical process control Quality and safety measurement, including mechanisms for gathering consumer feedback Incentives and other drivers of quality improvement Application of the principles of quality improvement to pharmacy practice -- complete with case examples
