In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of……続きを見る
Materials are the foundation of technology. As such, most universities provide engineering undergraduates with the fundamental concepts of materials science, including crystal structures, imperfecti……続きを見る
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation.……続きを見る
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and ……続きを見る
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure……続きを見る
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost……続きを見る
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. P……続きを見る
著者:Chunshan Song
出版社: Academic Press
発売日: 2016年11月23日
Advances in Catalysis fills the gap between journal papers and textbooks across the diverse areas of catalysis research. For more than 60 years, this series has dedicated itself to record and presen……続きを見る
著者:Chunshan Song
出版社: Academic Press
発売日: 2017年11月13日
Advances in Catalysis, Volume 60 fills the gap between journal papers and textbooks across the diverse areas of catalysis research, with this updated volume in the series covering Advances in Photoc……続きを見る
著者:Chunshan Song
出版社: Academic Press
発売日: 2017年11月17日
Advances in Catalysis, Volume 61, fills the gap between journal papers and textbooks across the diverse areas of catalysis research. For more than 60 years, this series has dedicated itself to recor……続きを見る
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. ……続きを見る
Praise for the Second Edition:
"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researc……続きを見る
In biotechnology and bioengineering, small molecules can be used to increase the efficiency reduce the cost and damage to the environment of certain bioprocesses. This book introduces readers to the……続きを見る
This book highlights the failure theories and evaluation techniques of thermal barrier coatings, covering the thermal-mechanical–chemical coupling theories, performance and damage characterization t……続きを見る
With interdisciplinary perspectives from internationally renowned experts, Noble-Metal-Free Electrocatalysts for Hydrogen Energy is one of the most authoritative references to focus solely on state-……続きを見る
This eBook+ version includes the following enhancements:
Interactive self-assessments at the end of each chapter help readers test their understanding of the concepts.
Active links to "extend you……続きを見る
Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes fi……続きを見る
By focusing on the theory and techniques of tribological design and testing for bearings, this book systematically reviews the latest advances in applications for this field. It describes advanced t……続きを見る
In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating ……続きを見る
This book is a concise but well-organized introduction to nanotechnology (NT) which the upstream oil industry is now vigorously adapting to develop its own unique applications for improved oilfield ……続きを見る
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a bro……続きを見る
This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosi……続きを見る
Unique in its focus on functional properties, this book examines the resistive, piezoresistive, thermoelectric, and electromagnetic behavior of multifunctional cement-based materials for reduced cos……続きを見る
This edited work covers diesel fuel chemistry in a systematic fashion from initial fuel production to the tail pipe exhaust. The chapters are written by leading experts in the research areas of anal……続きを見る