Blood substitutes are solutions designed for use in patients who need blood transfusions, but for whom whole blood is not available, or is not safe. This interest has intensified in the wake of the AIDS and hepatitis C epidemics. Blood Substitutes describes the rationale, current approaches, clinical efficacy, and design issues for all blood substitutes now in clinical trials. The many summary diagrams and tables help make the book accessible to readers such as surgeons and blood bankers, who have less technical expertise than the biochemists and hematologists who are designing and testing blood substitutes.* Includes chapters necessary to the understanding of blood substitutes, including history, toxicity, physiology, and clinical applications* Presents detailed descriptions of the various products that have been developed and have advanced to clinical trials, and some that are in earlier states of development

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Economic Evaluation in U.S. Health Care provides an overview of the methodologies that can be applied to both drug and non-drug interventions. The text addresses the perspectives of different stakeholders involved in the application of economic evaluation in the U.S., including manufacturers, health plans, and the government, in order to give students a thorough understanding of how methods are applied to decision-making and health policy. The authors provide case studies for students to apply methods to real life situations.