International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products, Sidebottom, Charles
Название: Handbook of Analysis of Oligonucleotides and Related Products ISBN: 1138198455 ISBN-13(EAN): 9781138198456 Издательство: Taylor&Francis Рейтинг: Цена: 84710.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Oligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. The Handbook of Analysis of Oligonucleotides and Related Products is an essential reference manual on the practical application of modern and emerging analytical techniques for the analysis of this unique class of compounds. A strong collaboration among thirty leading analytical scientists from around the world, the book provides readers with a comprehensive overview of the most commonly used analytical techniques and their advantages and limitations in assuring the identity, purity, quality, and strength of an oligonucleotide intended for therapeutic use. Topics discussed include: Strategies for enzymatic or chemical degradation of chemically modified oligonucleotides toward mass spectrometric sequencing Purity analysis by chromatographic or electrophoretic methods, including RP-HPLC, AX-HPLC, HILIC, SEC, and CGE Characterization of sequence-related impurities in oligonucleotides by mass spectrometry and chromatography Structure elucidation by spectroscopic methods (IR, NMR, MS) as well as base composition and thermal melt analysis (Tm) Approaches for the accurate determination of molar extinction coefficient of oligonucleotides Accurate determination of assay values Assessment of the overall quality of oligonucleotides, including microbial analysis and determination of residual solvents and heavy metals Strategies for determining the chemical stability of oligonucleotides The use of hybridization techniques for supporting pharmacokinetics and drug metabolism studies in preclinical and clinical development Guidance for the presentation of relevant analytical information towards meeting current regulatory expectations for oligonucleotide therapeutics This resource provides a practical guide for applying state-of-the-art analytical techniques in research, development, and manufacturing settings.
Автор: Rebecca Lynch; Conor Farrington Название: Quantified Lives and Vital Data ISBN: 1349957690 ISBN-13(EAN): 9781349957699 Издательство: Springer Рейтинг: Цена: 111790.00 T Наличие на складе: Нет в наличии. Описание: This book raises questions about the changing relationships between technology, people and health. It examines the accelerating pace of technological development and a general shift to personalized, patient-led medicine. Such relationships are increasingly mediated through particular medical technologies, drawn together by the authors as ‘personal medical devices’ (PMDs) – devices that are attached to, worn by, interacted with, or carried by individuals for the purposes of generating biomedical data and carrying out medical interventions on the person concerned. The burgeoning PMD field is advancing rapidly across multiple domains and disciplines – so rapidly that conceptual and empirical research and thinking around PMDs, and their clinical, social and philosophical implications, often lag behind new technical developments and medical interventions. This timely and original volume explores the significant and under-researched impact of personal medical devices on contemporary understandings of health and illness. It will be a valuable read for scholars and practitioners of medicine, health, science and technology and social science.
Автор: Lopez, Orlando Название: Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation ISBN: 1032094702 ISBN-13(EAN): 9781032094700 Издательство: Taylor&Francis Рейтинг: Цена: 33670.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement. Compliance is a state of being in
Автор: Justiniano, Jose , Gopalaswamy, Venky Название: Practical Design Control Implementation for Medical Devices ISBN: 036739538X ISBN-13(EAN): 9780367395384 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.
Автор: Shayne C. Gad Название: Safety Evaluation of Pharmaceuticals and Medical Devices ISBN: 148998187X ISBN-13(EAN): 9781489981875 Издательство: Springer Рейтинг: Цена: 130590.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The inspiration for this text was the 1988 volume by Alder and Zbinden. Since then, much has changed. But 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.
Автор: Rebecca Lynch; Conor Farrington Название: Quantified Lives and Vital Data ISBN: 1349952346 ISBN-13(EAN): 9781349952342 Издательство: Springer Рейтинг: Цена: 93160.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Such relationships are increasingly mediated through particular medical technologies, drawn together by the authors as `personal medical devices` (PMDs) - devices that are attached to, worn by, interacted with, or carried by individuals for the purposes of generating biomedical data and carrying out medical interventions on the person concerned.
Автор: Sidebottom, Charles Название: International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products ISBN: 0367395169 ISBN-13(EAN): 9780367395162 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Нет в наличии. Описание: Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.
Автор: Yasumaru Hatanaka; Makoto Hashimoto Название: Photoaffinity Labeling for Structural Probing Within Protein ISBN: 4431568239 ISBN-13(EAN): 9784431568230 Издательство: Springer Рейтинг: Цена: 139750.00 T Наличие на складе: Нет в наличии. Описание: This book covers the most up-to-date photoaffinity labeling method to tackle the key loop module involved in the binding process of a bioactive small molecule to its host protein.
Название: 3d printing in medicine and its role in the covid-19 pandemic ISBN: 3030619923 ISBN-13(EAN): 9783030619923 Издательство: Springer Рейтинг: Цена: 69870.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book describes how "makers" with no medical experience became and remain clinically important because they utilized 3D printing to produce supplies for healthcare, including medical and non-medical devices, and to improve the quality of life for patients with COVID-19 and those who care for them.
Автор: Wong Jack, Tong Raymond K. Y. Название: Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products ISBN: 9814877867 ISBN-13(EAN): 9789814877862 Издательство: Taylor&Francis Рейтинг: Цена: 197010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application.
Автор: Caroline Rodgers, Richard Harrington Название: Helping Hands: An Introduction to Diagnostic Strategy and Clinical Reasoning, First Edition ISBN: 1138330868 ISBN-13(EAN): 9781138330863 Издательство: Taylor&Francis Рейтинг: Цена: 112290.00 T Наличие на складе: Невозможна поставка. Описание: This brand-new textbook introduces medical students, junior doctors, medical educators and allied health professionals to the vital skills of diagnostic strategy and clinical reasoning, both essential components of becoming an effective clinician.
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