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A Guide to Pharmacovigilance Audits in the USA, Heather Murphy


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Автор: Heather Murphy
Название:  A Guide to Pharmacovigilance Audits in the USA
ISBN: 9783031735950
Издательство: Springer
Классификация:



ISBN-10: 3031735951
Обложка/Формат: Hardback
Страницы: 146
Вес: 0.00 кг.
Дата издания: 22.11.2024
Язык: English
Ключевые слова: Pharmacology,Pharmaceutics, Pharmacy
Основная тема: Biomedical and Life Sciences
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice. The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.
Дополнительное описание: Chapter 1 Introduction.- Chapter 2 Audit Types.- Chapter 3 PV Audit Preparation.- Chapter 4 PV Audit Conduct.- Chapter 5 Audit Report.- Chapter 6 Dos and Don’ts of a successful audit.



Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors in Heart Failure

Автор: Mukesh Nandave
Название: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors in Heart Failure
ISBN: 9819775671 ISBN-13(EAN): 9789819775675
Издательство: Springer
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Цена: 19514.00 р.
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Описание: The book delves into the development and therapeutic potential of Sodium-glucose Cotransporter-2 (SGLT2) inhibitors for the treatment of diabetes and cardiovascular diseases. It explores their mechanism of action, cardiovascular benefits, and role in primary and secondary protection from renal and cardiovascular diseases. The book also highlights their emerging opportunities in the management of myocardial infarction, diabetic cardiomyopathy, and congestive heart failure. It provides a comprehensive review of preclinical and clinical information on the cardiovascular advantages of SGLT2 inhibitors. Additionally, the book explores selective drugs and their effects on cardiovascular events, mortality, and safety outcomes in individuals with type 2 diabetes. The book is a valuable resource for researchers, healthcare professionals, and individuals interested in the field of SGLT2 inhibitors and their impact on diabetes and cardiovascular health.

Clinical Pharmacy Education, Practice and Research

Автор: Thomas, Dixon
Название: Clinical Pharmacy Education, Practice and Research
ISBN: 0128142766 ISBN-13(EAN): 9780128142769
Издательство: Elsevier Science
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Цена: 16505.00 р.
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Описание: Clinical Pharmacy Education, Practiceand Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practiceand Research provides an essential foundation for pharmacy students and pharmacists globally.

Essentials Of Pharmacovigilance

Автор: Baweja Himanshu
Название: Essentials Of Pharmacovigilance
ISBN: 9352704967 ISBN-13(EAN): 9789352704965
Издательство: JayPee Brothers India
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Цена: 7649.00 р.
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Описание: Contains a dedicated chapter of 100 Case Studies with answers for hand-on training and experience in Pharmacovigilance practices. Key points are given in the initial page of every chapter for chapter overview. Sample Model Papers comprising of MCQs, Case Study, Long and Short Answer questions are provided.

Cobert`s Manual of Drug Safety and Pharmacovigilance. 3 Ed

Автор: Barton Cobert, William W. Gregory, Jean-Loup Thoma
Название: Cobert`s Manual of Drug Safety and Pharmacovigilance. 3 Ed
ISBN: 9811215235 ISBN-13(EAN): 9789811215230
Издательство: World Scientific Publishing
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Цена: 8712.00 р.
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Описание:

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.

This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.

Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies -- both in the United States and around the world -- and provides critical information about what to do when confronted with a drug safety problem.

Ethnopharmacology and OMICS Advances in Medicinal Plants Volume 2

Автор: Mukesh Nandave
Название: Ethnopharmacology and OMICS Advances in Medicinal Plants Volume 2
ISBN: 9819742919 ISBN-13(EAN): 9789819742912
Издательство: Springer
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Цена: 19514.00 р.
Наличие на складе: Нет в наличии.

Описание: This book delves into diverse facets and applications of medicinal plants. It discusses the metabolic, transcriptomic, and genomic intricacies of medicinal plants, shedding light on their chemical compositions, genetic makeup, and regulatory mechanisms. It includes a chapter on nanotechnology, investigating the influence of nanoparticles on medicinal plants. Subsequent chapters explore functional genomics and genome editing, showcasing innovative approaches to modifying plant genetics. It also discusses plant-associated microorganisms in the microbiome and endophytic fungi. Furthermore, the book addresses the critical issues of genetic diversity, agrotechnology for sustainable production, intellectual property rights, and the impact of various stresses on medicinal plants.   This book serves as a valuable resource for researchers, educators, and students of pharmacology, offering a comprehensive understanding of medicinal plants and their evolving role in science and medicine.  

Pharmacoepidemiology and Pharmacovigilance

Автор: Plourde, Gilles
Название: Pharmacoepidemiology and Pharmacovigilance
ISBN: 0128161833 ISBN-13(EAN): 9780128161838
Издательство: Elsevier Science
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Цена: 19875.00 р.
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Описание:

Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety.

The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations.

  • Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs
  • Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions
  • Offers case studies that illustrate real-life clinical situations
  • Discusses important concepts related to pharmacoepidemiology and pharmacovigilance
Angiotensin-converting Enzyme Inhibitors vs. Angiotensin Receptor Blockers

Автор: Mukesh Nandave
Название: Angiotensin-converting Enzyme Inhibitors vs. Angiotensin Receptor Blockers
ISBN: 9819773792 ISBN-13(EAN): 9789819773794
Издательство: Springer
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Цена: 19514.00 р.
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Описание: This book delves into the various aspects of the renin-angiotensin-aldosterone system (RAAS) and its role in cardiovascular disorders. It explores the use of anti-hypertensive agents, with a focus on (ACE) angiotensin-converting enzyme inhibitors and angiotensin receptor blockers (ARBs). The chapters cover topics such as the preferred use of ACE inhibitors over ARBs in high-risk patients, the impact of these agents on insulin resistance, their role in acute heart failure and peripheral artery disease, and their immunomodulatory activity in hypertensive patients. Additionally, the book examines the role of ACE inhibitors and ARBs in COVID-19 patients and provides insights into recent trends in managing hypertension through RAAS inhibition. It serves as a valuable resource for researchers, clinicians, and healthcare professionals involved in the field of cardiovascular medicine.

Drug Repurposing

Автор: Naveen Chella
Название: Drug Repurposing
ISBN: 9819750156 ISBN-13(EAN): 9789819750153
Издательство: Springer
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Цена: 26832.00 р.
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Описание: This book offers an insightful exploration of drug repurposing, an innovative approach to drug discovery and development that has the potential to revolutionize the field of medicine. It begins with an introduction to drug repurposing and its history, providing a comprehensive overview of the subject. The readers will embark on a journey through the diverse landscape of drug repurposing strategies. From in silico methods of predicting drug-disease associations to experimental approaches to the integrations of artificial intelligence (AI) and machine learning (ML) in drug repurposing for validating repurposed candidates. The book also delves into the application of drug repurposing in various disease areas, including cancer, inflammatory disorders, and CNS disorders. It explores the potential hurdles involved in the regulatory aspects of the process. The book further covers drug products under clinical trials and provides an overview of the future perspectives of drug repurposing. With its detailed and informative content, this book is a must-read for researchers, clinicians, and healthcare professionals interested in the exciting field of drug repurposing.

Pharmacovigilance

Автор: I. Ralph Edwards; Marie Lindquist
Название: Pharmacovigilance
ISBN: 3319403990 ISBN-13(EAN): 9783319403991
Издательство: Springer
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Цена: 18294.00 р.
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Описание: Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.

Pharmacovigilance: Volume 2

Автор: Charmy S. Kothari, Manan Shah
Название: Pharmacovigilance: Volume 2
ISBN: 1803561254 ISBN-13(EAN): 9781803561257
Издательство: Mare Nostrum (Eurospan)
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Цена: 20374.00 р.
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Описание: This book discusses various topics in pharmacovigilance. The first section addresses such topics as approaches to minimise adverse drug reactions, different stakeholders and their importance in pharmaceutical policy development, changing needs for pharmacovigilance in the African region, machine learning applications in pharmacovigilance, and pharmacovigilance of biological drugs. The second section discusses signal detection, which is a promising approach that helps in the early identification of new, rare drug reactions (desired or undesired).

Signal analysis in pharmacovigilance

Название: Signal analysis in pharmacovigilance
ISBN: 1032629703 ISBN-13(EAN): 9781032629704
Издательство: Taylor&Francis
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Цена: 13781.00 р.
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Understanding Allergic Airway Diseases

Автор: Parteek Prasher
Название: Understanding Allergic Airway Diseases
ISBN: 9819719526 ISBN-13(EAN): 9789819719525
Издательство: Springer
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Цена: 19514.00 р.
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Описание: The book explores the intersection of nanotechnology and allergic airway diseases. With a focus on diagnosis and management, each chapter delves into specific areas of interest. Beginning with an introduction to the diseases, the book progresses to uncover the pathophysiology and immunology underlying allergic airway diseases. The epidemiology chapter provides insights into the prevalence and impact of these conditions. A significant portion of the book is dedicated to nanotechnology applications, with chapters on metal and metal oxide nanoparticles, nanomicelles, carbon nanotubes, liposomes, polymeric nanoparticles, solid lipid nanoparticles, dendrimers, nanofibers, and quantum dots. These chapters delve into the potential of these nanomaterials in managing allergic airway diseases, highlighting their unique properties, and promising therapeutic approaches. Finally, the book concludes with a chapter on future directions, exploring emerging trends and potential advancements in the field. This book will be a valuable resource for academics, caregivers, researchers, and industry professionals working in the field of airway allergic diseases. It includes translational and clinical researchers, under-graduates and postgraduates (Masters), PhDs, and post-doctoral researchers of various disciplines, including pharmaceutical sciences, biotechnology, immunology, and medical and health sciences.


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