Benefit-Risk Assessment Methods in Medical Product Development, Jiang, Qi
Автор: Lipscomb Название: Outcomes Assessment in Cancer ISBN: 1107403162 ISBN-13(EAN): 9781107403161 Издательство: Cambridge Academ Рейтинг: Цена: 9203.00 р. 13147.00-30% Наличие на складе: Есть (1 шт.) Описание: Cancer has profound effects on patients and families, but measuring outcomes such as quality of life poses unique challenges. This volume, first published in 2005, provides a penetrating yet practical discussion of alternative approaches for comprehensively measuring the burden of cancer and the effectiveness of preventive and therapeutic interventions.
Описание: This book provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks.
Автор: Harry Salem; Sidney A. Katz Название: Toxicity Assessment Alternatives ISBN: 147576863X ISBN-13(EAN): 9781475768633 Издательство: Springer Рейтинг: Цена: 18284.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Choudhry Muneeb Название: Get Ahead! The Prescribing Safety Assessment ISBN: 1498719066 ISBN-13(EAN): 9781498719063 Издательство: Taylor&Francis Рейтинг: Цена: 3980.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Get ahead The Prescribing Safety Assessmentis an invaluable practice aid for students preparing for final exams. Written by an experienced team of authors under the guidance of series editor Saran Shantikumar, it covers two examinations' worth of questions matching the exact format of the Prescribing Safety Assessment (PSA). Candidates can work through the practice papers systematically or dip in and out of the book using the index as a guide to questions on a specific topic.
Автор: Patricia B. Curry; Sesh Iyengar; Pamela A. Maloney Название: Methods of Pesticide Exposure Assessment ISBN: 1489909753 ISBN-13(EAN): 9781489909756 Издательство: Springer Рейтинг: Цена: 23508.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Proceedings of a workshop held in Ottawa, Ontario, Canada, October 5-8, 1993
Автор: Patricia B. Curry; Sesh Iyengar; Pamela A. Maloney Название: Methods of Pesticide Exposure Assessment ISBN: 0306451301 ISBN-13(EAN): 9780306451300 Издательство: Springer Рейтинг: Цена: 28732.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Proceedings of a workshop held in Ottawa, Ontario, Canada, October 5-8, 1993
Автор: Kamae Название: Health Technology Assessment in Japan ISBN: 9811357927 ISBN-13(EAN): 9789811357923 Издательство: Springer Рейтинг: Цена: 9781.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Representing the first book on the topic, this work offers the reader an introduction to the Japanese systems for health technology assessment (HTA) officially introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2016. Policy and guidelines are discussed, with the relevant methods and conditions of cost-effectiveness analysis explained alongside. Numerous instructive examples and exercises, ranging from basic to advanced, impart valuable knowledge and insight on the quantitative methods for economic evaluation, which will appeal to both beginners and experts. This guidebook is authored by Japan’s foremost expert in HTA and pharmacoeconomics, with a view to strengthening the reader’s expertise in value-based healthcare and decision-making. The methods presented are essential to informing regulatory, local and patient decisions; as such, the book is equally recommended to industry and government, as well as academia, and anyone with an interest in Japanese HTA.
Описание: While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials - largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released).
Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. * Identify and verify the most appropriate available data.
* As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. * As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. * As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required.
* Incorporating assessments for special populations such as neonates. * Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. * Performance and presentation of integrative assessments covering all potential biologic risks.
Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Автор: James Leong; Sam Salek; Stuart Walker Название: Benefit-Risk Assessment of Medicines ISBN: 331915804X ISBN-13(EAN): 9783319158044 Издательство: Springer Рейтинг: Цена: 11878.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions;
Автор: James Leong; Sam Salek; Stuart Walker Название: Benefit-Risk Assessment of Medicines ISBN: 3319367676 ISBN-13(EAN): 9783319367675 Издательство: Springer Рейтинг: Цена: 11179.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions;
Описание: "This book discusses recent advancements in the field of QSARs with special reference to their application in drug development, predictive toxicology, and chemical risk analysis"--Provided by publisher.
Автор: Fisher, Jeffrey Название: Physiologically-Based Pharmacokinetic (Pbpk) Modeling ISBN: 0128185961 ISBN-13(EAN): 9780128185964 Издательство: Elsevier Science Рейтинг: Цена: 23075.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Physiologically Based Pharmacokinetic (PBPK) Modeling: Methods and Applications in Toxicology and Risk Assessment presents foundational principles, advanced techniques and applications of PBPK modeling. Contributions from experts in PBPK modeling cover topics such as pharmacokinetic principles, classical physiological models, the application of physiological models for dose-response and risk assessment, the use of in vitro information, and in silico methods. With end-of-chapter exercises that allow readers to practice and learn the skills associated with PBPK modeling, dose-response, and its applications to safety and risk assessments, this book is a foundational resource that provides practical coverage of PBPK modeling for graduate students, academics, researchers, and more.
Provides end-of-chapter exercises to teach hands-on computational tools used in toxicology
Supplies computer code and explanations and includes examples of applied models used in regulatory toxicology and research
Authored by expert editors and contributors who are among the best PBPK modelers in the world
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