Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices. The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market-ready devices. Also incorporated are new case examples and citations with the means of access to Internet-based regulatory and scientific sites, reflecting the universal adoption of this technology into our world. The book takes into consideration the fact that device markets are global, the continual advancement of technology, and the increasing global harmonization of safety regulations. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives.

The gastrointestinal tract is the most important of the three major routes of entry (and clearance) of xenobiotics and biologic entities into the bodies of mammals. As such, it is also the major route for administration of pharmaceuticals to humans. Gastrointestinal Toxicology, Second Edition describes the mechanism for entry and clearance of xenobiotics, as well as the barriers, immunologic and metabolic issues, and functions present in the GI tract. Appearing in this volume are also considerations of the microbiome and its actions and influence on the function of the GI tract and on the toxicity and pharmacodynamics of ingested substances (including nutrients, toxins, and therapeutics). These fifteen chapters written by experienced experts in the field address methods to evaluate GI function; specifics of GI function and toxicity assessment in canines and minipigs; classes of compounds with their toxicity; species differences; and the toxicity (and promise) of nanoparticles. Those needing to understand the structure, function, and methods of studying the GI tract will find this volume a singular source of reference.

Toxicology of the Gastrointestinal Tract focuses on the specifics of the mechanisms and adverse effects of xenobiotic agents and pharmaceuticals on the structure and function of the GI tract. The book focuses on a number of specific areas of intestinal research. Beginning with the well-recognized and major functions of nutrient absorption and its role as a protective barrier, the text elaborates on the expanding body of knowledge that relates to the intestines as a major metabolic and immunologic organ involved in the synthesis and degradation of both natural and foreign substances. It includes an overview of the function and dysfunction of the human absorptive process and the effects of microbial flora on these processes, as well as specific classes of toxicants that target the GI tract. The international panel of contributors presents a critical appraisal of the interactions of chemicals and drugs with the gastrointestinal system and the experimental methods and regions of research on which to focus future efforts.

Providing a complete and multidisciplinary overview of the gastrointestinal system both in health and as it is involved in the toxicity of exogenous agents, Toxicology of the Gastrointestinal Tract brings together the current and growing knowledge of this critical organ system in a single volume.