Bioequivalence and Statistics in Clinical Pharmacology, Jones, Byron Patterson, Scott D. (Pfizer Vaccines Clinical Research & Development, Collegeville, Pennsylvania, USA)
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the
USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Название: Generic drug product development ISBN: 036738437X ISBN-13(EAN): 9780367384371 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
Автор: Lawrence X. Yu; Bing V. Li Название: FDA Bioequivalence Standards ISBN: 1493912518 ISBN-13(EAN): 9781493912513 Издательство: Springer Рейтинг: Цена: 167700.00 T Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Macheras Название: Revising Oral Pharmacokinetics, Bioavailability and Bioequivalence Based on the Finite Absorption Time Concept ISBN: 3031200241 ISBN-13(EAN): 9783031200243 Издательство: Springer Рейтинг: Цена: 139750.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book casts new light on the field of oral drug absorption. It outlines both the concept of the past and the novel concept of Finite Absorption Time (FAT). In addition, the authors explore the correlated need for re-definition of bioavailability, bioequivalence providing a plethora of experimental data. Accordingly, this book is intended for academics/students or scientists working in pharmaceutical industries, regulatory agencies, and contract research organizations. It can be used for teaching purposes in under- and post-graduate courses dealing with biopharmaceutics, pharmacokinetics and biomedical engineering.
Автор: Lawrence X. Yu; Bing V. Li Название: FDA Bioequivalence Standards ISBN: 1493955586 ISBN-13(EAN): 9781493955589 Издательство: Springer Рейтинг: Цена: 130430.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
.- 1 Bioequivalence History
.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu
.- 2 Fundamentals of Bioequivalence
.- Mei-Ling Chen
.- 3 Basic Statistical Considerations
.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann
.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence
.- Wayne I. DeHaven and Dale P. Conner
.- 5 Biowaiver and Biopharmaceutics Classification System
.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu
.- 6 Bioequivalence of Highly Variable Drugs
.- Barbara M. Davit and Devvrat T. Patel
.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu
.- 8 Bioequivalence for Narrow Therapeutic Index Drugs
Автор: Stephen L. George, Xiaofei Wang, Herbert Pang Название: Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis ISBN: 0367261170 ISBN-13(EAN): 9780367261177 Издательство: Taylor&Francis Рейтинг: Цена: 50010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. The book covers state-of-the-art approaches to the design and analysis of cancer clinical trials, such as adaptive designs, biomarker-based trials, and dynamic treatment regimes.
Автор: Chow, Shein-chung Shao, Jun Wang, Hansheng Название: Sample size calculations in clinical research, third edition ISBN: 1138740985 ISBN-13(EAN): 9781138740983 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. This new edition contains updates and four new chapters written specifically for this version.
Автор: Matsui Shigeyuki Название: Design and Analysis of Clinical Trials for Predictive Medicine ISBN: 1466558156 ISBN-13(EAN): 9781466558151 Издательство: Taylor&Francis Рейтинг: Цена: 117390.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics--from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.
This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.
Название: Modern Adaptive Randomized Clinical Trials ISBN: 1482239884 ISBN-13(EAN): 9781482239881 Издательство: Taylor&Francis Рейтинг: Цена: 163330.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive randomization designs? Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects answers these questions and more. From novel designs to cutting-edge applications, this book presents several new and key developments in adaptive randomization. It also offers a fresh and critical look at a number of already-classical topics. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and the pharmaceutical industry, the text: Clarifies the taxonomy of the concept of adaptive randomization Discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selection Gives an exposition to many novel adaptive randomization techniques such as brick tunnel randomization, targeted least absolute shrinkage and selection operator (LASSO)-based CARA randomization, multi-arm multi-stage (MAMS) designs, to name a few Addresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designs Describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma Explores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects covers a wide spectrum of topics related to adaptive randomization designs in contemporary clinical trials. The book provides a thorough exploration of the merits of adaptive randomization and aids in identifying when it is appropriate to apply such designs in practice.
Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study.
Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies.
The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement.
Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.
Автор: Alex Dmitrienko, Erik Pulkstenis Название: Clinical Trial Optimization Using R ISBN: 0367261251 ISBN-13(EAN): 9780367261252 Издательство: Taylor&Francis Рейтинг: Цена: 50010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The book defines a unified framework for clinical trial optimization based on a comprehensive quantitative evaluation of relevant clinical scenarios (using the clinical scenario evaluation approach) and introduce best practices for simulationbased optimization.
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