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As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Safety Assessment presents a histopathologic description of lesions observed during drug development and discusses their implication in the drug development process. Divided into two sections, the book systematically assists pathologists in making a determination as to the origin and potential importance of a lesion and its relevance for assessing hum...
The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Select topics include: Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology. Current approaches to carcinogenicity testing. Predicting drug-drug interactions. Current understanding of idiosyncratic drug reaction. Asse...
Retroviruses have been of great importance to biomedical science for the past half century. Initially, studies on oncogenic animal retroviruses provided important insights into molecular processes in carcinogenesis – most notably the existence and mechanisms of action of oncogenes and proto-oncogenes. Moreover, several human diseases are caused by retroviruses, including AIDS, adult T-cell leukemia and the neurological disease HAM/TSP. The topic of this volume is a relatively unknown animal retrovirus, jaagsiekte sheep retrovirus, the causative agent of transmissible lung cancer in sheep –ovine pulmonary adenocarcinoma. The disease was first documented in South Africa in the 1800s, it has a wide geographical distribution, and it is of economic importance in high endemic regions. However, until very recently the nature of the etiologic agent was unclear, and relatively few laboratories actively studied the disease.
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There has been a growing interest in toxicologic pathology, especially as related to its impact on the safety assessment of pharmaceuticals and chemicals, and in drug development. Thus, there is a growing need for an Illustrated Dictionary of Toxicology Pathology and Safety Science (IDTP) that this dictionary aims to fill. The language of toxicologic pathology may be less familiar to a broad range of safety scientists, especially those involved in the safety evaluation of pharmaceuticals and chemicals. The IDTP format provides the brevity and clarity that the user is not likely to receive in a textbook, even if adequately indexed. With the inclusion of descriptions for terms used in toxicolo...
The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Spontaneous Pathology of the Laboratory Non-human Primate serves as a "go to" resource for all pathologists working on primates in safety assessment studies. In addition, it helps diagnostic veterinary pathologists rule out spontaneous non-clinical disease pathologies when assigning cause of death to species in zoological collections. Primate species included are rhesus, cynomolgus macaques and marmosets. Multi-authored chapters are arranged by organ system, thus providing the necessary information for continued research.Pathologists often face a lack of suitable reference materials or historical data to determine if pathologic changes they are observing in monkeys are spontaneous or a consequence of other treatments or factors. - Contains color illustrations that depict the most common lesions to augment descriptions - Covers descriptions that are compliant with the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) guidelines set forth by the Society of Toxicologic Pathology (STP) - Provides pathologists with common terms that are compliant with the FDA's Standard for Exchange of Nonclinical Data (SEND) guidelines
Fundamentals of Toxicologic Pathology, Third Edition, presents an essential overview of systems toxicologic pathology in a clear-and-concise manner. Toxicologic pathology integrates toxicology and its interdisciplinary components, including biochemistry, pharmacodynamics and risk assessment to pathology and its related disciplines, such as physiology, microbiology, immunology and molecular biology. This wholly revised and updated edition presents the newest information on the topic, and is an essential reference for advanced students, early career researchers, toxicologic pathologists, pharmaceutical scientists, medical pathologists and clinicians, and anyone involved with drug and device de...
Vols. for 1915-49 and 1956- include the Proceedings of the annual meeting of the association.