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9 produkter
9 produkter
2 680 kr
Skickas inom 10-15 vardagar
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.
2 839 kr
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There has been an enormous growth of interest in the field of toxicologic pathology and particularly on its impact on nonclinical safety assessment in global drug development and in the environment. Toxicologic pathologists play an important role in detecting test article-related adverse effects by characterizing morphologic changes in animal tissues and/or body fluids under prescribed study conditions or less clearly defined conditions in the environment and in the interpretation of these findings relative to human risk. In fact, pathology evaluation is often the single most important decision-making factor in nonclinical safety assessments as 80% of drug candidate attrition has been attributed to pathology findings in toxicity studies. There are currently no primers or basic overviews covering the field of toxicologic pathology, whereas there are at least several basic books that cover the sister field of toxicology.Toxicologic Pathology: A Primer is a practical, easy-to-use reference designed to contain core information provided by board-certified veterinary pathologists, all experts in the field. The Primer contains the basic, underlying principles of toxicologic pathology at the introductory level; thus it will be valuable to the veterinary pathology student who may be considering a career in the field as well as a companion to the seasoned toxicologic pathologist who wants a succinct refresher. The Primer is arranged as chapters presenting each major organ system preceded by an overview chapter covering the field of toxicologic pathology followed by a “concept” chapter describing the role of toxicologic pathology in drug development. Photomicrographs and illustrations provide visual context.The organ system chapters provide histopathologic descriptions of lesions observed in toxicity studies of test articles in drug development and testing of chemicals that may negatively impact the environment. Each organ system chapter provides additional information related to a particular lesion to aid the reader in better understanding its toxicologic significance relative to human risk.Each organ system chapter contains:A brief introductionA succinct description of the anatomy and physiology of the systemDescriptions of the most important pathological lesionsDifferential diagnosesBiological consequences, pathogenesis, and/or mechanism of lesion formationAssociated clinical pathology correlatesNonclinical safety scientists such as study directors, non-pathology-oriented contributing scientists such as senior toxicology report reviewers, scientific management of Contract Research Organizations (CROs), and students should find the Primer useful in helping them understand the fundamentals of toxicologic pathology.
2 627 kr
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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.Assessing cardiovascular risks beyond QT interval.Use of 3D cell cultures in toxicology and ADME.Development of small molecule-antibody complexes.Differentiating adverse from non-adverse findings in nonclinical studies.Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
3 759 kr
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Over the past few decades, there has been an exponential growth of interest in the field of toxicologic pathology, a critical field in safety science, particularly as related to its impact on nonclinical safety in global drug development and care of the environment. Photomicrographic examples of selected nonproliferative and proliferative lesions are necessary to complement the written narratives in textbooks on toxicologic pathology. Toxicologic Pathology: An Atlas fits that need with input provided by top experts in the field. It will become a valuable reference, not only for toxicologic pathologists, but also for a wide variety of nonclinical safety scientists, especially in the pharmaceutical and biotech industries.This book provides illustrations and descriptions of commonly observed findings in toxicologic pathology (i.e., over 1100 photomicrographic examples). These illustrations add visual context to the terms and descriptions commonly used in the field. The illustrations and accompanying descriptions were prepared and peer reviewed by editors and contributors who are known experts in toxicologic pathology, toxicology, and drug development. The Atlas is designed to be practical, easy to use and written with the hope that it will become a reliable "go-to" reference that will be of interest to students and nonscientists (e.g., individuals serving on animal care and use committees) as a key, single source to understanding terminology and visualizing tissue changes described by toxicologic pathologists.
4 043 kr
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The new edition provides practical and timely information for toxicologic pathologists working in drug discovery and development. The introductory concept chapters are consolidated into two more concise and better-organized introductory chapters. The two concept chapters introduce the reader to pharmaceutical R&D, the role of the pathologist in the process, and critical partner scientific disciplines with whom the pathologist will collaborate. In this revision, the organ system chapters incorporate more consistent commentary and guidance on the molecular mechanism of action, human translational relevance, and regulatory impact of pathological findings as they are described in these chapters.Key Features:Aids scientists in understanding spontaneously occurring and compound-related pathological findingsFeatures three new well-respected scientists on the editorial teamIncludes more consistent commentary and guidance in the organ system chapters
3 150 kr
Kommande
This third volume in the series focuses on such germane issues as the weight of evidence approach, the 3Rs, (Replacement, Reduction, and Refinement) personalized drug therapies, and oncology therapeutics, among others. Volumes in this series are aimed at toxicologists and toxicologic pathologists involved in drug development. Volumes in the Current Topics in Nonclinical Drug Development series are aimed at toxicologists, toxicologic pathologists, regulators, and study directors, dealing with issues in study design, evaluation of findings, and presentation of data. In addition, the series will serve as an aid to academicians and graduate students studying nonclinical drug development.Key Features:Explores the critical issues and current topics important in nonclinical drug developmentDeals with day-to-day issues in study design, evaluation of findings, and presentation of dataAids academicians and graduate students pursuing research related to nonclinical drug developmentDelves into both the art and science of nonclinical drug development and its impact on translational medicine and human safety
2 911 kr
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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 human risk. The first section includes eight "concept" chapters to orient pathologists in areas that are important for effective interaction with other pathologists as well as the many non-pathologists involved in drug development. The second section is made up of organ-based chapters, each including light microscopic and electron microscopic descriptions of pathological lesions, differential diagnoses, biological consequences, pathogenesis, mechanism of lesion formation, and the expected clinical pathology correlates. This volume presents critical information—both published and unpublished and gained through personal experience—to improve the quality of drug safety evaluation and to expedite and improve the efficiency of the process. This book is crafted to assist students, residents, and toxicologic pathologists in their early career phase by serving as a resource that can effectively be used as a ready reference next to the microscope. In addition, more experienced pathologists will find this volume to be invaluable during their assessments. The book is also a valuable reference for toxicologists to assist in understanding compound-related pathological findings and to provide background for working on a range of toxicological problems.
4 567 kr
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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.
3 335 kr
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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 toxicology, drug metabolism/pharmacokinetics, and regulatory science, the scope of the IDTP is considerably broadened and decidedly unique in its appeal to all safety scientists. With over 800 photos and illustrations to provide visual context,* an important aim of the IDTP is to present pathological changes as reference examples for terminology, nomenclature, and term descriptions for the entry entry-level as well as seasoned toxicologic pathologist. It will also aid students and non-pathology specialists such as study directors, senior toxicology report reviewers, scientific management of contract research organizations, regulatory agencies, and drug development companies to better understand the biological significance of tissue changes. The IDTP provides a single reference volume for these users to further their understanding and appreciation of biologically significant pathology findings. The IDTP consists of four major areas:1. A-Z Dictionary of Pathology encompassing all organ systems, together with relevant non-pathology terms supported by references in "For Further Reading" sections.2. Appendix 1: An Overviews of Drug Development, Nonclinical Safety & Toxicologic Pathology, and Important/Special Topics.3. Appendix 2: Diagnostic Criteria of for Proliferative Proliferative Lesions in Rodents (Rat and Mouse) and Selected Non-Rodent Laboratory Species containing illustrations with detailed references and links to source material.4) Appendix 3: Mini-Atlas of Organ System Anatomy and Histology to help re-acquaint the non-pathologist safety scientist with many normal anatomical structures.The editors and contributing scientists (board-certified veterinary pathologists, board-certified toxicologists, allied health safety scientists, health regulatory representatives) have experience from bench-level pathology and toxicology to managing global preclinical safety units in leading pharmaceutical companies. They have considerable experience mentoring pharmaceutical industry project team members, interacting with industry clinicians and representatives of decision-making bodies within the industry, as well as with global health authorities, such as the FDA and EMA. These activities convinced them of the necessity for and usefulness of the IDTP. As experts in their field, they have undertaken the hard work of writing and compiling the information, making the IDTP an exceptional, go-to reference.*Illustrations Editor: Gregory Argentieri