Bioequivalence and Statistics in Clinical Pharmacology,
Старое издание
Автор: Patterson Название: Bioequivalence and Statistics in Clinical Pharmacology ISBN: 1584885300 ISBN-13(EAN): 9781584885306 Издательство: Taylor&Francis Цена: 13168.00 р. Наличие на складе: Поставка под заказ. Описание: Bioequivalence and Statistics in Clinical Pharmacology covers the applications and basic elements of the theory of statistical methods in clinical pharmacology. It establishes techniques used in the assessment of bioequivalence and describes the use of statistics in clinical pharmacology studies of safety, ECG monitoring, efficacy, and population pharmacokinetics. The authors demonstrate study design, analysis, and interpretation of data using real data examples. The book emphasizes regulatory applications related to drug development and features a wide range of datasets as well as SAS and SPLUS code available on the Internet.
Автор: Patterson Название: Bioequivalence and Statistics in Clinical Pharmacology ISBN: 1584885300 ISBN-13(EAN): 9781584885306 Издательство: Taylor&Francis Рейтинг: Цена: 13168.00 р. Наличие на складе: Поставка под заказ.
Описание: Bioequivalence and Statistics in Clinical Pharmacology covers the applications and basic elements of the theory of statistical methods in clinical pharmacology. It establishes techniques used in the assessment of bioequivalence and describes the use of statistics in clinical pharmacology studies of safety, ECG monitoring, efficacy, and population pharmacokinetics. The authors demonstrate study design, analysis, and interpretation of data using real data examples. The book emphasizes regulatory applications related to drug development and features a wide range of datasets as well as SAS and SPLUS code available on the Internet.
Автор: Niazi Sarfaraz K Название: Handbook Of Bioequivalence Testing ISBN: 0849303958 ISBN-13(EAN): 9780849303951 Издательство: Taylor&Francis Цена: 22968.00 р. Наличие на складе: Поставка под заказ.
Описание: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.
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: 22202.00 р. 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.
Название: Modern Adaptive Randomized Clinical Trials ISBN: 1482239884 ISBN-13(EAN): 9781482239881 Издательство: Taylor&Francis Рейтинг: Цена: 24499.00 р. 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.
Описание: Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
Название: Clinical Trial Optimization using R ISBN: 149873507X ISBN-13(EAN): 9781498735070 Издательство: Taylor&Francis Рейтинг: Цена: 16078.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making.
This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
Автор: Yuan Название: Bayesian Designs for Phase I–II Clinical Trials ISBN: 1498709559 ISBN-13(EAN): 9781498709552 Издательство: Taylor&Francis Рейтинг: Цена: 16078.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book is the first to focus on Bayesian phase I-II clinical trials. It describes many problems with the conventional phase I-phase II paradigm and covers a large number of modern Bayesian phase I-II clinical trial designs.
Описание: Clinical trials require strategic thinking and innovative methods since some traditional methods are not adequate for the 21st century.To solve these problems requires good methodological skills, but also an in-depth knowledge of the practical problems we are dealing with and a strategic vision of the pig picture.
Автор: Vinod P. Shah; Howard I. Maibach; John Jenner Название: Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 1493912887 ISBN-13(EAN): 9781493912889 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.
Автор: Broglio, Kristine ; Yu, Binbing Название: Case Studies in Innovative Clinical Trials ISBN: 1032262656 ISBN-13(EAN): 9781032262659 Издательство: Taylor&Francis Рейтинг: Цена: 21437.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Jones, Byron Patterson, Scott D. (Pfizer Vaccines Clinical Research & Development, Collegeville, Pennsylvania, USA) Название: Bioequivalence and Statistics in Clinical Pharmacology ISBN: 0367782448 ISBN-13(EAN): 9780367782443 Издательство: Taylor&Francis Рейтинг: Цена: 7348.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explor
Название: Generic drug product development ISBN: 036738437X ISBN-13(EAN): 9780367384371 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. 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.
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