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
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
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed.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
Bio-based polymers are materials that are produced from renewable resources. Their biodegradable properties are the driver of worldwide interest among researchers and manufacturers in recent years d……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
Biotechnology of Major Cereals focuses on the recent advances and future prospects in cereal biotechnology. The first part of the book covers the world's major cereals and focus on new developments ……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
著者：Deborah D L Chung
出版社： World Scientific Publishing Company
発売日： 2013年09月09日
This is Volume 2 of the book series The Road to Scientific Success: Inspiring Life Stories of Prominent Researchers. Authoritative scientists describe their life experiences in relation to how succe……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
This book presents the key technology of electronic noses, and systematically describes how e-noses can be used to automatically analyse odours. Appealing to readers from the fields of artificial in……続きを見る
