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Fundamentals of International Regulatory Affairs
Laws and regulations governing healthcare product marketing submissions in multiple geographies.
Fundamentals of Us Regulatory Affairs 2005
Directives and regulations governing healthcare products in the EU.
Exploring Inductive Risk
This book brings together eleven case studies of inductive risk-the chance that scientific inference is incorrect-that range over a wide variety of scientific contexts and fields. The chapters are designed to illustrate the pervasiveness of inductive risk, assist scientists and policymakers in responding to it, and productively move theoretical discussions of the topic forward.
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Scientific Directory and Annual Bibliography
Presents the broad outline of NIH organizational structure, theprofessional staff, and their scientific and technical publications covering work done at NIH.
Location Directory
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Issues in Risk Assessment
The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume. The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures. The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.
