A Toxicologist s Guide to Clinical Pathology in Animals

A Toxicologist s Guide to Clinical Pathology in Animals
Author: John E. Whalan
Publsiher: Unknown
Total Pages: 135
Release: 2015
ISBN: 9783319158549
Category: Electronic Book
Language: EN, FR, DE, ES & NL

A Toxicologist s Guide to Clinical Pathology in Animals Book Excerpt:

This guide provides an easy-to-use desk reference for diagnostic information on commonly used hematology, clinical chemistry, and urinalysis parameters. Additional reference materials are provided as an aid in evaluating clinical pathology data. For many toxicologists, the evaluation of hematology, clinical chemistry, and urinalysis data can be the most challenging aspect of animal toxicity studies. In a typical toxicity study, dozens of parameters are measured several times over the course of the study. There may be hundreds of data points, each of which needs to be considered. A Toxicologist's Guide to Clinical Pathology in Animals will serve as an essential primer for toxicologists in training and in industry as well as for researchers and professionals in a veterinary practice or a laboratory.

A Toxicologist s Guide to Clinical Pathology in Animals

A Toxicologist s Guide to Clinical Pathology in Animals
Author: John E. Whalan
Publsiher: Springer
Total Pages: 151
Release: 2015-03-25
ISBN: 3319158538
Category: Medical
Language: EN, FR, DE, ES & NL

A Toxicologist s Guide to Clinical Pathology in Animals Book Excerpt:

This guide provides an easy-to-use desk reference for diagnostic information on commonly used hematology, clinical chemistry and urinalysis parameters. Additional reference materials are provided as an aid in evaluating clinical pathology data. For many toxicologists, the evaluation of hematology, clinical chemistry and urinalysis data can be the most challenging aspect of animal toxicity studies. In a typical toxicity study, dozens of parameters are measured several times over the course of the study. There may be hundreds of data points, each of which needs to be considered. A Toxicologist’s Guide to Clinical Pathology in Animals will serve as an essential primer for toxicologists in training and in industry as well as for researchers and professionals in a veterinary practice or a laboratory.

A Practical Guide to Toxicology and Human Health Risk Assessment

A Practical Guide to Toxicology and Human Health Risk Assessment
Author: Laura Robinson
Publsiher: John Wiley & Sons
Total Pages: 400
Release: 2018-11-05
ISBN: 1118882075
Category: Science
Language: EN, FR, DE, ES & NL

A Practical Guide to Toxicology and Human Health Risk Assessment Book Excerpt:

Toxicology – the study of the adverse effects of chemicals on living organisms is the cornerstone to all aspects of chemical safety and knowledge of the subject is needed in a wide spectrum of fields from the chemical industry to medicine, emergency services, forensics, and regulatory science. Toxicology involves the study of symptoms, mechanisms, treatments and detection of poisoning ... especially the poisoning of people. The many problems arising from a poor understanding of toxicology and its applications in hazard communication and chemical safety motivated the author’s training courses and webinars, leading to this valuable book. Providing a practical and accessible guide, A Practical Guide to Toxicology and Human Health Risk Assessment enables readers to quickly build up knowledge and understanding of toxicology and its use in hazard identification, which is a fundamental part of chemical risk assessment. The book also covers current toxicological testing strategies and the use of physicochemical test data in hazard identification and exposure assessment. Examples are provided throughout the book to highlight important issues along with a summary of the key points that have been covered in each of the respective chapters. The book concludes with a listing of online resources on toxicology and risk assessment.

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: 0123878152
Category: Medical
Language: EN, FR, DE, ES & NL

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

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

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: 0128036214
Category: Medical
Language: EN, FR, DE, ES & NL

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

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

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: 0470922729
Category: Medical
Language: EN, FR, DE, ES & NL

Pharmaceutical Toxicology in Practice Book Excerpt:

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.

Handbook of Toxicology

Handbook of Toxicology
Author: Michael J. Derelanko,Carol S. Auletta
Publsiher: CRC Press
Total Pages: 1022
Release: 2014-03-07
ISBN: 1439890145
Category: Law
Language: EN, FR, DE, ES & NL

Handbook of Toxicology Book Excerpt:

The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics r

Interpharm Master Keyword Guide

Interpharm Master Keyword Guide
Author: Interpharm
Publsiher: CRC Press
Total Pages: 736
Release: 2003-05-27
ISBN: 1420025872
Category: Medical
Language: EN, FR, DE, ES & NL

Interpharm Master Keyword Guide Book Excerpt:

The bestselling and most useful aid available for finding all references to FDA and DEA regulations, Interpharm Master Keyword Guide: 21 CFR Regulations of the Food and Drug Administration, is used in hundreds of active pharmaceuticals, pharmaceutical, biotechnology, diagnostic, and device manufacturing companies. And it is in use by every FDA district in the United States to sort their way through their own regulations. Each of the over 20,000 entries is quoted in context to provide instant access to every noun, phrase, and concept used by the DEA and FDA. The KEYWORD and SECTION TITLE are shown in upper case, the Subpart Title and/or Part Title are shown in capitals and lower case. How to use this guide: 1. Look up the keyword of interest 2. Note the context in which the keyword is mentioned in the section of title and the details of the subpart or part title to determine if it is the reference you need 3. When you find the correct reference, use the section number provided to look up the details of the regulations in the Code of Federal Regulations Title 21 Updated to include the latest changes in 21 CFR, the Interpharm Master Keyword Guide: 21 CFR Regulations of the Food and Drug Administration, 2002-2003 Edition makes it easy to find the exact section you need and apply it correctly.

Nonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring
Author: William F. Salminen,Joe M. Fowler,James Greenhaw
Publsiher: Academic Press
Total Pages: 262
Release: 2012-12-31
ISBN: 0123978319
Category: Medical
Language: EN, FR, DE, ES & NL

Nonclinical Study Contracting and Monitoring Book Excerpt:

Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step. Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues. Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process. Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book.

Encyclopedia of Tissue Engineering and Regenerative Medicine

Encyclopedia of Tissue Engineering and Regenerative Medicine
Author: Anonim
Publsiher: Academic Press
Total Pages: 1418
Release: 2019-06-03
ISBN: 0128137002
Category: Science
Language: EN, FR, DE, ES & NL

Encyclopedia of Tissue Engineering and Regenerative Medicine Book Excerpt:

Encyclopedia of Tissue Engineering and Regenerative Medicine provides a comprehensive collection of personal overviews on the latest developments and likely future directions in the field. By providing concise expositions on a broad range of topics, this encyclopedia is an excellent resource. Tissue engineering and regenerative medicine are relatively new fields still in their early stages of development, yet they already show great promise. This encyclopedia brings together foundational content and hot topics in both disciplines into a comprehensive resource, allowing deeper interdisciplinary research and conclusions to be drawn from two increasingly connected areas of biomedicine. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the fields of tissue engineering and regenerative medicine Contains multimedia features, including hyperlinked references and further readings, cross-references and diagrams/images Represents the most comprehensive and exhaustive product on the market on the topic

Animal Hematotoxicology

Animal Hematotoxicology
Author: G.O. Evans
Publsiher: CRC Press
Total Pages: 224
Release: 2008-07-25
ISBN: 9781420080100
Category: Medical
Language: EN, FR, DE, ES & NL

Animal Hematotoxicology Book Excerpt:

Hematology data from in vivo toxicology studies remains one of the most predictive measures for human risk, as the same measurements made in pre-clinical toxicology studies can be made in early clinical trials. Covering the three main blood cell types – erythrocytes, leukocytes and thrombocytes, this work is designed to clarify topics for new entrants to the fields of laboratory animal hematology and toxicology, especially those topics where the rules for human hematology do not always apply. An entire chapter is devoted to immunotoxicology, a scientific discipline that is closely aligned with hematology. The text also addresses pre-analytical and analytical variables that affect animal studies, as these play a far more important part when interpreting data in contrast to humans where many of these variables can be well controlled or have less physiological effect. Information has been collated from published papers, textbooks and unpublished data: Readers are provided with key references to encourage further study

Animal Models in Toxicology

Animal Models in Toxicology
Author: Shayne C. Gad
Publsiher: CRC Press
Total Pages: 1152
Release: 2016-04-05
ISBN: 1466554290
Category: Medical
Language: EN, FR, DE, ES & NL

Animal Models in Toxicology Book Excerpt:

Animal Models in Toxicology is a single-source reference for the use of animal models in toxicology. Chapters cover nine species used in toxicology and experimental biology. With contributions from experts in toxicology, toxicological pathology, and species-specific metabolism, each of these chapters provides an excellent introductory "course" alon

The Clinical Chemistry of Laboratory Animals

The Clinical Chemistry of Laboratory Animals
Author: David M. Kurtz,Gregory S. Travlos
Publsiher: CRC Press
Total Pages: 1162
Release: 2017-10-18
ISBN: 142009114X
Category: Medical
Language: EN, FR, DE, ES & NL

The Clinical Chemistry of Laboratory Animals Book Excerpt:

Key features: Serves as the detailed, authoritative source of the clinical chemistry of the most commonly used laboratory animals Includes detailed chapters dedicated to descriptions of clinical chemistry-related topics specific to each laboratory species as well as organ/class-specific chapters Presents information regarding evaluation and interpretation of a variety of individual clinical chemistry end points Concludes with detailed chapters dedicated to descriptions of statistical analyses and biomarker development of clinical chemistry-related topics Provides extensive reference lists at the end of each chapter to facilitate further study Extensively updated and expanded since the publication of Walter F. Loeb and Fred W. Quimby’s second edition in 1999, the new The Clinical Chemistry of Laboratory Animals, Third Edition continues as the most comprehensive reference on in vivo animal studies. By organizing the book into species- and organ/class-specific chapters, this book provides information to enable a conceptual understanding of clinical chemistry across laboratory species as well as information on evaluation and interpretation of clinical chemistry data relevant to specific organ systems. Now sponsored by the American College of Laboratory Animal Medicine (ACLAM), this well-respected resource includes chapters on multiple laboratory species and provides pertinent information on their unique physiological characteristics, methods for sample collection, and preanalytical sources of variation for the particular species. Basic methodology for common procedures for each species is also discussed. New Chapters in the Third Edition Include: The Laboratory Zebrafish and Other Fishes Evaluation of Cardiovascular and Pulmonary Function and Injury Evaluation of Skeletal Muscle Function and Injury Evaluation of Bone Function and Injury Vitamins Development of Biomarkers Statistical Methods The Clinical Chemistry of Laboratory Animals, Third Edition is intended as a reference for use by veterinary students, clinical veterinarians, verterinary toxicologists, veterinary clinical pathologists, and laboratory animal veterinarians to aid in study design, collection of samples, and interpretation of clinical chemistry data for laboratory species.

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment
Author: National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Board on Environmental Studies and Toxicology,Committee on Applications of Toxicogenomic Technologies to Predictive Toxicology
Publsiher: National Academies Press
Total Pages: 300
Release: 2007-11-19
ISBN: 9780309178891
Category: Science
Language: EN, FR, DE, ES & NL

Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment Book Excerpt:

The new field of toxicogenomics presents a potentially powerful set of tools to better understand the health effects of exposures to toxicants in the environment. At the request of the National Institute of Environmental Health Sciences, the National Research Council assembled a committee to identify the benefits of toxicogenomics, the challenges to achieving them, and potential approaches to overcoming such challenges. The report concludes that realizing the potential of toxicogenomics to improve public health decisions will require a concerted effort to generate data, make use of existing data, and study data in new ways--an effort requiring funding, interagency coordination, and data management strategies.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 918
Release: 2016-12-01
ISBN: 111909741X
Category: Medical
Language: EN, FR, DE, ES & NL

Drug Safety Evaluation Book Excerpt:

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Environmental Health Perspectives

Environmental Health Perspectives
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2009-07
ISBN: 1928374650XXX
Category: Environmental health
Language: EN, FR, DE, ES & NL

Environmental Health Perspectives Book Excerpt:

Hazardous Materials Toxicology

Hazardous Materials Toxicology
Author: John Burke Sullivan,Gary R. Krieger
Publsiher: Unknown
Total Pages: 1242
Release: 1992
ISBN: 1928374650XXX
Category: Medical
Language: EN, FR, DE, ES & NL

Hazardous Materials Toxicology Book Excerpt:

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals
Author: Joy A. Cavagnaro
Publsiher: John Wiley & Sons
Total Pages: 1064
Release: 2013-03-07
ISBN: 1118679385
Category: Medical
Language: EN, FR, DE, ES & NL

Preclinical Safety Evaluation of Biopharmaceuticals Book Excerpt:

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: Includes an overview of biopharmaceuticals with information onregulation and methods of production Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.

Haschek and Rousseaux s Handbook of Toxicologic Pathology

Haschek and Rousseaux s Handbook of Toxicologic Pathology
Author: Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig
Publsiher: Academic Press
Total Pages: 3054
Release: 2013-05-01
ISBN: 0124157653
Category: Medical
Language: EN, FR, DE, ES & NL

Haschek and Rousseaux s Handbook of Toxicologic Pathology Book Excerpt:

Haschek and Rousseaux's Handbook of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. The 3e has been expanded by a full volume, and covers aspects of safety assessment not discussed in the 2e. Completely revised with many new chapters, it remains the most authoritative reference on toxicologic pathology for scientists and researchers studying and making decisions on drugs, biologics, medical devices and other chemicals, including agrochemicals and environmental contaminants. New topics include safety assessment, the drug life cycle, risk assessment, communication and management, carcinogenicity assessment, pharmacology and pharmacokinetics, biomarkers in toxicologic pathology, quality assurance, peer review, agrochemicals, nanotechnology, food and toxicologic pathology, the environment and toxicologic pathology and more. Provides new chapters and in-depth discussion of timely topics in the area of toxicologic pathology and broadens the scope of the audience to include toxicologists and pathologists working in a variety of settings Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology Features hundreds of full color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

Biochemical and Organic Compounds for Research and Diagnostic Clinical Reagents

Biochemical and Organic Compounds for Research and Diagnostic Clinical Reagents
Author: Sigma Chemical Company
Publsiher: Unknown
Total Pages: 135
Release: 1995
ISBN: 1928374650XXX
Category: Chemicals
Language: EN, FR, DE, ES & NL

Biochemical and Organic Compounds for Research and Diagnostic Clinical Reagents Book Excerpt: