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The content of this book is intended to provide the toxicologist in drug development in the pharmaceutical and biotechnology industries with a broad understanding of bone and its interactions with other organ systems in safety assessments. The book is divided into three parts. The first part describes our current understanding of bone biology and its primary regulatory pathways. Additional chapters address regulatory and study design considerations for incorporating bone end points in toxicology studies, with special consideration being given to juvenile toxicology studies. This is intended to address recent regulatory requirements to evaluate skeletal development for drugs in development fo...
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This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.
Unemployment among black Americans is twice that of whites. Myriad theories have been put forward to explain the persistent employment gap between blacks and whites in the U.S. Structural theorists point to factors such as employer discrimination and the decline of urban manufacturing. Other researchers argue that African-American residents living in urban neighborhoods of concentrated poverty lack social networks that can connect them to employers. Still others believe that African-American culture fosters attitudes of defeatism and resistance to work. In Lone Pursuit, sociologist Sandra Susan Smith cuts through this thicket of competing explanations to examine the actual process of job sea...
This book sets out a clear framework for conducting participatory research with children and young people within a discussion of the rights of the child. Through extensive case studies and a close review of contemporary literature, in relation to early childhood through to late adolescence, the book serves as a critical guide to issues in participative research for students and researchers. The book includes chapters on: Designing your research project Ethical considerations Innovative methods Publication and dissemination.