Hands On Approach for the Conduct of Nonclinical Studies

Hands On Approach for the Conduct of Nonclinical Studies
Author: Deven Dandekar,Pallavi B. Limaye
Publsiher: Academic Press
Total Pages: 365
Release: 2019-03
ISBN 10: 9780128131008
ISBN 13: 0128131004
Language: EN, FR, DE, ES & NL

Hands On Approach for the Conduct of Nonclinical Studies Book Review:

Hands-on Approach for the Conduct of Nonclinical Studies: A Manual for Anticipating and Avoiding Potential Problems focuses on practical approaches to real-life challenges faced during nonclinical studies, providing insights into the anticipation of potential problems and solutions to problems which may arise, saving time, money and resources. The book outlines Good Laboratory Practice in detail and includes regulatory guidelines, communication, stakeholder information and case studies. It is essential reading for study directors/technical coordinators, quality assurance personnel, all technical staff and project managers. In addition, it offers guidance for those new to the area, while also acting as a reference for senior researchers. Includes an introduction to Good Laboratory Practice (GLP) scenarios and the related regulations Explains aspects of study directorship, including documentation, document review, implementation and execution of preclinical studies Provides a detailed account of the responsibilities of each stakeholder (technical, managerial, sponsor) within the study and how timely they need to act to seamlessly move a project

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
Author: Alberto Lodola,Jeanne Stadler
Publsiher: John Wiley & Sons
Total Pages: 280
Release: 2011-03-31
ISBN 10: 0470922729
ISBN 13: 9780470922729
Language: EN, FR, DE, ES & NL

Pharmaceutical Toxicology in Practice Book Review:

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Targeted Therapy in Translational Cancer Research

Targeted Therapy in Translational Cancer Research
Author: Apostolia-Maria Tsimberidou,Razelle Kurzrock,Kenneth C. Anderson
Publsiher: John Wiley & Sons
Total Pages: 320
Release: 2015-10-08
ISBN 10: 1118468686
ISBN 13: 9781118468685
Language: EN, FR, DE, ES & NL

Targeted Therapy in Translational Cancer Research Book Review:

Targeted Therapy in Translational Cancer Research for the Translational Oncology series provides a comprehensive overview of recent developments in our understanding of tumor biology, elucidates the roles of targets and pathways involved in carcinogenesis, and describes current state-of-the-art anticancer therapy, as well as the most promising areas of translational research and targeted therapy. Introduces cutting-edge ‘bench to bedside and back’ breakthroughs which have transformed the diagnosis, prognosis, and treatment of cancer Covers basic principles of targeted therapy, including immunotherapy and the roles of cancer stem cells, the microenvironment, angiogenesis, epigenetics, microRNAs, and functional imaging in precision medicine Summarises major advances in therapeutic management of hematologic malignancies and solid tumors using conventional therapy, targeted therapy, immunotherapy, or novel treatment modalities

Translational Medicine

Translational Medicine
Author: Joy A. Cavagnaro,Mary Ellen Cosenza
Publsiher: CRC Press
Total Pages: 542
Release: 2021-11-26
ISBN 10: 1000471829
ISBN 13: 9781000471823
Language: EN, FR, DE, ES & NL

Translational Medicine Book Review:

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.

Nonclinical Safety Assessment

Nonclinical Safety Assessment
Author: William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publsiher: John Wiley & Sons
Total Pages: 488
Release: 2013-03-05
ISBN 10: 1118516982
ISBN 13: 9781118516980
Language: EN, FR, DE, ES & NL

Nonclinical Safety Assessment Book Review:

Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Global Approach in Safety Testing

Global Approach in Safety Testing
Author: Jan Willem van der Laan,Joseph J DeGeorge
Publsiher: Springer Science & Business Media
Total Pages: 315
Release: 2013-02-11
ISBN 10: 1461459508
ISBN 13: 9781461459507
Language: EN, FR, DE, ES & NL

Global Approach in Safety Testing Book Review:

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
Author: William J. Brock,Barbara Mounho,Lijie Fu
Publsiher: John Wiley & Sons
Total Pages: 560
Release: 2014-05-02
ISBN 10: 1118874080
ISBN 13: 9781118874080
Language: EN, FR, DE, ES & NL

The Role of the Study Director in Nonclinical Studies Book Review:

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Handbook of Bioequivalence Testing

Handbook of Bioequivalence Testing
Author: Sarfaraz K. Niazi
Publsiher: CRC Press
Total Pages: 1007
Release: 2014-10-29
ISBN 10: 1482226383
ISBN 13: 9781482226386
Language: EN, FR, DE, ES & NL

Handbook of Bioequivalence Testing Book Review:

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

Brain Computer Interfaces for Non clinical Home Sports Art Entertainment Education Well being Applications

Brain Computer Interfaces for Non clinical  Home  Sports  Art  Entertainment  Education  Well being  Applications
Author: Anton Nijholt,Jose Luis Contreras-Vidal,Camille Jeunet,Aleksander Väljamäe
Publsiher: Frontiers Media SA
Total Pages: 135
Release: 2022-03-17
ISBN 10: 2889747174
ISBN 13: 9782889747177
Language: EN, FR, DE, ES & NL

Brain Computer Interfaces for Non clinical Home Sports Art Entertainment Education Well being Applications Book Review:

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
Author: William J. Brock,Barbara Mounho,Lijie Fu
Publsiher: John Wiley & Sons
Total Pages: 545
Release: 2014-06-03
ISBN 10: 1118370392
ISBN 13: 9781118370391
Language: EN, FR, DE, ES & NL

The Role of the Study Director in Nonclinical Studies Book Review:

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
Author: Ali S. Faqi
Publsiher: Academic Press
Total Pages: 986
Release: 2016-11-03
ISBN 10: 0128036214
ISBN 13: 9780128036211
Language: EN, FR, DE, ES & NL

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book Review:

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Management of Animal Care and Use Programs in Research Education and Testing

Management of Animal Care and Use Programs in Research  Education  and Testing
Author: Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
Publsiher: CRC Press
Total Pages: 872
Release: 2017-09-07
ISBN 10: 1498748457
ISBN 13: 9781498748452
Language: EN, FR, DE, ES & NL

Management of Animal Care and Use Programs in Research Education and Testing Book Review:

AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author: Ali S. Faqi
Publsiher: Academic Press
Total Pages: 885
Release: 2012-11-16
ISBN 10: 0123878152
ISBN 13: 9780123878151
Language: EN, FR, DE, ES & NL

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book Review:

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

Good Research Practice in Non Clinical Pharmacology and Biomedicine

Good Research Practice in Non Clinical Pharmacology and Biomedicine
Author: Anton Bespalov,Martin C. Michel,Thomas Steckler
Publsiher: Springer Nature
Total Pages: 424
Release: 2020-01-01
ISBN 10: 3030336565
ISBN 13: 9783030336561
Language: EN, FR, DE, ES & NL

Good Research Practice in Non Clinical Pharmacology and Biomedicine Book Review:

This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Principles of Safety Pharmacology

Principles of Safety Pharmacology
Author: Michael K. Pugsley,Michael J Curtis
Publsiher: Springer
Total Pages: 481
Release: 2015-06-19
ISBN 10: 366246943X
ISBN 13: 9783662469439
Language: EN, FR, DE, ES & NL

Principles of Safety Pharmacology Book Review:

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 150
Release: 2010-10-22
ISBN 10: 9780309163354
ISBN 13: 0309163358
Language: EN, FR, DE, ES & NL

Transforming Clinical Research in the United States Book Review:

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Principles of Research Data Audit

Principles of Research Data Audit
Author: Adil E. Shamoo
Publsiher: Taylor & Francis
Total Pages: 181
Release: 1989
ISBN 10: 9782881243790
ISBN 13: 2881243797
Language: EN, FR, DE, ES & NL

Principles of Research Data Audit Book Review:

First Published in 1989. Routledge is an imprint of Taylor & Francis, an informa company.

Handbook of LC MS Bioanalysis

Handbook of LC MS Bioanalysis
Author: Wenkui Li,Jie Zhang,Francis L. S. Tse
Publsiher: John Wiley & Sons
Total Pages: 704
Release: 2013-09-03
ISBN 10: 111867135X
ISBN 13: 9781118671351
Language: EN, FR, DE, ES & NL

Handbook of LC MS Bioanalysis Book Review:

Consolidates the information LC-MS bioanalytical scientistsneed to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by newapproaches for developing bioanalytical methods, new liquidchromatographic (LC) techniques, and new mass spectrometric (MS)instruments. Moreover, there are a host of guidelines andregulations designed to ensure the quality of bioanalyticalresults. Presenting the best practices, experimental protocols, and thelatest understanding of regulations, this book offers acomprehensive review of LC-MS bioanalysis of small molecules andmacromolecules. It not only addresses the needs of bioanalyticalscientists working on routine projects, but also explores advancedand emerging technologies such as high-resolution mass spectrometryand dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions froman international team of leading bioanalytical scientists. Theircontributions reflect a review of the latest findings, practices,and regulations as well as their own firsthand analyticallaboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drugdevelopment, and therapeutic drug monitoring The current understanding of regulations governing LC-MSbioanalysis Best practices and detailed technical instructions for LC-MSbioanalysis method development, validation, and stabilityassessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MSbioanalysis of challenging molecules, including pro-drugs, acylglucuronides, N-oxides, reactive compounds, and photosensitive andautooxidative compounds With its focus on current bioanalytical practice, Handbook ofLC-MS Bioanalysis enables bioanalytical scientists to developand validate robust LC-MS assay methods, all in compliance withcurrent regulations and standards.

Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science

Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science
Author: Panda, Mrutyunjaya,Misra, Harekrishna
Publsiher: IGI Global
Total Pages: 392
Release: 2021-01-08
ISBN 10: 1799866610
ISBN 13: 9781799866619
Language: EN, FR, DE, ES & NL

Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science Book Review:

In today’s digital world, the huge amount of data being generated is unstructured, messy, and chaotic in nature. Dealing with such data, and attempting to unfold the meaningful information, can be a challenging task. Feature engineering is a process to transform such data into a suitable form that better assists with interpretation and visualization. Through this method, the transformed data is more transparent to the machine learning models, which in turn causes better prediction and analysis of results. Data science is crucial for the data scientist to assess the trade-offs of their decisions regarding the effectiveness of the machine learning model implemented. Investigating the demand in this area today and in the future is a necessity. The Handbook of Research on Automated Feature Engineering and Advanced Applications in Data Science provides an in-depth analysis on both the theoretical and the latest empirical research findings on how features can be extracted and transformed from raw data. The chapters will introduce feature engineering and the recent concepts, methods, and applications with the use of various data types, as well as examine the latest machine learning applications on the data. While highlighting topics such as detection, tracking, selection techniques, and prediction models using data science, this book is ideally intended for research scholars, big data scientists, project developers, data analysts, and computer scientists along with practitioners, researchers, academicians, and students interested in feature engineering and its impact on data.

Toxicologic Pathology

Toxicologic Pathology
Author: Pritam S. Sahota,James A. Popp,Jerry F. Hardisty,Chirukandath Gopinath,Page Bouchard
Publsiher: CRC Press
Total Pages: 1224
Release: 2018-08-31
ISBN 10: 0429997450
ISBN 13: 9780429997457
Language: EN, FR, DE, ES & NL

Toxicologic Pathology Book Review:

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.