Quantitative Evaluation of Safety in Drug Development, Jiang, Qi
Название: Real-World Evidence in Drug Development and Evaluation ISBN: 036702621X ISBN-13(EAN): 9780367026219 Издательство: Taylor&Francis Рейтинг: Цена: 19906.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book concerns use of real world data (RWD) and real world evidence (RWE) to aid drug development across product cycle. RWD are healthcare data that are collected outside the constraints of conventual controlled randomized trials (CRTs); whereas RWE is the knowledge derived from aggregation and analysis of RWD.
Описание: Proteins are exposed to various interfacial stresses during drug product development. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies.
State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.
The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation.
Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
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: O`Connell Ann A., McCoach D. Betsy, Bell Bethany A. Название: Multilevel Modeling Methods with Introductory and Advanced Applications ISBN: 1648028713 ISBN-13(EAN): 9781648028717 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 11920.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Provides a cogent and comprehensive introduction to the area of multilevel modeling for methodological and applied researchers as well as advanced graduate students. The topics range from basic to advanced, yet each chapter is designed to be able to stand alone as an instructional unit on its respective topic.
Автор: O`Connell Ann A., McCoach D. Betsy, Bell Bethany A. Название: Multilevel Modeling Methods with Introductory and Advanced Applications ISBN: 1648028721 ISBN-13(EAN): 9781648028724 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 17186.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Provides a cogent and comprehensive introduction to the area of multilevel modeling for methodological and applied researchers as well as advanced graduate students. The topics range from basic to advanced, yet each chapter is designed to be able to stand alone as an instructional unit on its respective topic.
Автор: Shayne C. Gad Название: Safety Evaluation of Pharmaceuticals and Medical Devices ISBN: 148998187X ISBN-13(EAN): 9781489981875 Издательство: Springer Рейтинг: Цена: 19589.00 р. 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: Hugo Kubinyi; Gerd Folkers; Yvonne C. Martin Название: 3D QSAR in Drug Design ISBN: 0792347919 ISBN-13(EAN): 9780792347910 Издательство: Springer Рейтинг: Цена: 39182.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Significant progress has been made in the study of three-dimensional quantitative structure-activity relationships (3D QSAR) since the first publication by Richard Cramer in 1988 and the first volume in the series, 3D QSAR in Drug Design.
Автор: Chuang-Stein Christy, Kirby Simon Название: Quantitative Decisions in Drug Development ISBN: 3319834347 ISBN-13(EAN): 9783319834344 Издательство: Springer Рейтинг: Цена: 9083.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Clinical Testing of a New Drug.- A Frequentist Decision-making Framework.- Characteristics of a Diagnostic Test.- The Parallel Between Clinical Trials and Diagnostic Tests.- Incorporating Information from Completed Trials in Future Trial Planning.- Choosing Metrics Appropriate for Different Stages of Drug Development.- Designing Proof-of-Concept Trials with Desired Characteristics.- Designing Dose-response Studies with Desired Characteristics.- Designing Confirmatory Trials with Desired Characteristics.- Designing Phase 4 Trials.- Other Metrics That Have Been Proposed to Optimize Drug Development Decisions.- Discounting Prior Results to Account for Selection Bias.- Index.- Appendix.
Автор: Chuang-stein, Christy Kirby, Simon Название: Quantitative decisions in drug development ISBN: 3030797309 ISBN-13(EAN): 9783030797300 Издательство: Springer Рейтинг: Цена: 8384.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug.
Автор: Chen, Jie Название: Medical Product Safety Evaluation ISBN: 036757117X ISBN-13(EAN): 9780367571177 Издательство: Taylor&Francis Рейтинг: Цена: 7348.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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