Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

During the years that have intervened since the third volume of the International Life Seiences Institute (ILSI) Monographs on Pathology of Laboratory Animals, Digestive System, was published, new information of interest to pathologists has developed at a rather remarkable pace. Standardized nomenclature has been proposed and gained significant acceptance during the period since the first edition and isbeing utilized on aninternational basis. Thishas resulted in improvement in communi cationof pathologic data to reguiatory agencies and inscientific publica tions worldwide. This monograph series and others sponsored by ILSI have had significant effects on improved communications and the inter national acceptance of standardized nomenclature. In this second edition, new formats have been used in some instances where more appropriate for the subjects to be eovered. The format introduced in the first edition remains useful as it emphasizes the neces sityto reeognize the morphologie features of pathologic lesions to iden tify them precisely. This identifieation is an essential first step toward development of new insightsintopathogenetic meehanismsand their use in decisions eventually applieable to public health. Newinformation is included in thisedition on the nature and variability of preneoplastic lesions in the Iiver of laboratory rodents. Data on the aeeompanying changes in enzyme activity in affeeted Iiver cells are ex panded, and additional information on spongiosis hepatis in the rat and its relation to spongiotic pericytoma is a further feature. In a few in stanees, research on a pathologie entity has been Iimitedbut its recogni tionremains important. Thisjustifiesinclusion of suchentities in the new edition."