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The Role of the Study Director in Nonclinical Studies
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Nonclinical Safety Assessment
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a p...
Taiping Guangji; A Collection of Ancient Novels in China; The Volume of Personalities (Vol. 165 – 196)
"Taiping Guangji" （太平广记） is the first collection of ancient classical Chinese documentary novels. The book has 500 volumes with 10 catalogues . It is a kind of book based on the documentary stories of the Han Dynasty and the Song Dynasty. 14 people including Li Fang, Hu Mongolian ﹑ Li Mu , Xu Xuan , Wangke Zhen , Song white , Lv Wenzhong worked under Song Taizong Emperor’s command for the compilation. It began in the second year of Taiping Xingguo (977 A.D) and was completed in the following year (978 Ad.). This book is basically a collection of ancient stories compiled by category. The book is divided into 92 categories according to the theme, and is divided into more than 1...
The Role of the Study Director in Nonclinical Studies
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Chinese Maritime Cases
This book selects leading, innovative and influential Chinese maritime judgments and presents full translation of them, with brief summary, to the readers so that they can have insights of how the Chinese maritime judges interpret, apply and develop Chinese maritime law in practice. China trades with other states in trillions of USD every year, and about 95% of the cargoes are carried by ocean-going ships calling at hundreds of Chinese ports each single day. Due to the enormous and steadily growing trade volume and shipping activities, foreign ships, companies and persons are often caught by the Chinese maritime law and court. The parties involved and their lawyers are more than ever enthusi...
Beyond Exemplar Tales
“Clear, coherent, richly documented, and highly persuasive. I know of no other source devoted exclusively to the topic of Chinese women’s biographies, and I am confident that this book will have a ready audience in the China field and beyond.” -Paul Ropp, Clark University “In addition to Liu Xiang’s Lienü zhuan, the Urtext of Chinese women’s biography, this rich trove of essays explores previously unexamined biographical genres and mines literary texts for their biographical potential. It will be of great value to scholars interested in women’s history, life-writing, and biography, both in the China field and in comparative contexts.” -Grace S. Fong, McGill University
The Writ of the Three Sovereigns
In 648 CE, Tang imperial authorities collected every copy of the Writ of the Three Sovereigns (Sanhuang wen) from the four corners of the empire and burned them. The formidable talismans at its core were said not only to extend their owners’ lifespan and protect against misfortune, but also propel them to stratospheric heights of power, elevating them to the rank of high minister or even emperor. Only two or three centuries earlier, this controversial text was unknown in most of China with the exception of Jiangnan in the south, where it was regarded as essential local lore. In the span of a few generations, the Writ of the Three Sovereigns would become the cornerstone of one of the three ...
China Reconstructs
China Reconstructs includes ten articles that investigate the reconstruction of modern China and provide different dimensions to the vibrant and multifaceted history of the country. The book discusses how prominent individuals, political parties, and ordinary people alike looked for ways to "reconstruct China" in a period of great political upheavals.
