"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."

This handbook addresses the needs of those who are involved in inventing, developing, and testing implants and are concerned about the interactions between biomaterial and body tissue. The authors explore the physical, chemical, mechanical and regulatory considerations of synthetic materials used in surgical and implant procedures, and how these factors impact the latest developments and new approaches. This updated edition provides the biomaterials professional with necessary information on a range of issues, including bulk characterization, surface evaluations, toxicological evaluations, in vitro methods for safety evaluation, methods for evaluating materials in special applications, surgical considerations, systems implantology, soft and hard tissue history, regulatory aspects, and clinical trials.

"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."

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

This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

A complete, up-to-date guide to the leading product testing standard Fully revised to cover the latest nondestructive testing (NDT) procedures, this practical resource reviews established and emerging methods for examining materials without destroying them or altering their structure. Handbook of Nondestructive Evaluation, Second Edition offers in-depth details on the background, benefits, limitations, and applications of each method. The book provides advice on how to interpret results and formulate accurate decisions based on your findings. New chapters on digital radiography, ultrasonic phased array testing, and ultrasonic guided wave inspection are included. This is a must-have reference for NDT certification candidates, engineers, metallurgists, quality control specialists, and anyone involved in product design, manufacture, or maintenance. Handbook of Nondestructive Evaluation, Second Edition covers: Introduction to nondestructive testing Discontinuities—origins and classification Visual testing Penetrant testing Magnetic particle testing Radiographic testing Ultrasonic testing Eddy current testing Thermal infrared testing Acoustic emission testing Digital radiography Ultrasonic phased array testing Ultrasonic guided wave inspection