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: 87790 T 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: 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: 48990.00 T 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
Автор: Patterson Название: Bioequivalence and Statistics in Clinical Pharmacology ISBN: 1584885300 ISBN-13(EAN): 9781584885306 Издательство: Taylor&Francis Рейтинг: Цена: 87790.00 T 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.
Название: Clinical Trial Optimization using R ISBN: 149873507X ISBN-13(EAN): 9781498735070 Издательство: Taylor&Francis Рейтинг: Цена: 107190.00 T 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: 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: 149060.00 T 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: 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: Niazi Sarfaraz K Название: Handbook Of Bioequivalence Testing ISBN: 0849303958 ISBN-13(EAN): 9780849303951 Издательство: Taylor&Francis Цена: 153120.00 T 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: Vinod P. Shah; Howard I. Maibach; John Jenner Название: Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 1493938568 ISBN-13(EAN): 9781493938568 Издательство: Springer Рейтинг: Цена: 121890.00 T 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.
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: Macheras Название: Revising Oral Pharmacokinetics, Bioavailability and Bioequivalence Based on the Finite Absorption Time Concept ISBN: 3031200276 ISBN-13(EAN): 9783031200274 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: Broglio, Kristine ; Yu, Binbing Название: Case Studies in Innovative Clinical Trials ISBN: 1032262656 ISBN-13(EAN): 9781032262659 Издательство: Taylor&Francis Рейтинг: Цена: 142910.00 T Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Susan Halabi, Stefan Michiels Название: Textbook of Clinical Trials in Oncology: A Statistical Perspective ISBN: 1138083771 ISBN-13(EAN): 9781138083776 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This is a textbook on the design and analysis of cancer clinical trials. It opens with a discussion of the choice of endpoints before moving onto discuss various types of trials across all phases of study, including basket trials, non-inferiority trials and multi-arm trials.
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