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Author: Ronald D. Hood
Publisher: CRC Press
ISBN: 1420040545
Category : Medical
Languages : en
Pages : 1168
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Book Description
Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers evaluating and interpreting data. Originally titled Handbook of Developmental Toxicology, the second edition's new name reflects significant changes in its content and scope. New coverage in the Second Edition: Genomics and proteomics Tests for endocrine disruptors Testing for male and female reproductive toxicity Extensive treatment of the significance, reliability, and interpretation of developmental and reproductive toxicity data Toxicity testing in neonatal and juvenile animals Postnatal developmental milestones FDA perspective on risk assessment Extensive glossaries of developmental defect terminology Previous books on this subject have largely been academically oriented and not intended to guide the practicing developmental or reproductive toxicologist. Useful and informative, this book blends the theoretical foundation with insights gained from hands-on experience. It includes tables of comparative developmental milestones - both pre- and postnatal, glossaries of descriptive terms used in developmental toxicity evaluation, and both US and international regulatory guidelines. Bridging the gap between theory and application, this is a handy single-source of essential information to use in planning, conducting, and interpreting studies.
Author: Ronald D. Hood
Publisher: CRC Press
ISBN: 1420040545
Category : Medical
Languages : en
Pages : 1168
Get Book
Book Description
Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers evaluating and interpreting data. Originally titled Handbook of Developmental Toxicology, the second edition's new name reflects significant changes in its content and scope. New coverage in the Second Edition: Genomics and proteomics Tests for endocrine disruptors Testing for male and female reproductive toxicity Extensive treatment of the significance, reliability, and interpretation of developmental and reproductive toxicity data Toxicity testing in neonatal and juvenile animals Postnatal developmental milestones FDA perspective on risk assessment Extensive glossaries of developmental defect terminology Previous books on this subject have largely been academically oriented and not intended to guide the practicing developmental or reproductive toxicologist. Useful and informative, this book blends the theoretical foundation with insights gained from hands-on experience. It includes tables of comparative developmental milestones - both pre- and postnatal, glossaries of descriptive terms used in developmental toxicity evaluation, and both US and international regulatory guidelines. Bridging the gap between theory and application, this is a handy single-source of essential information to use in planning, conducting, and interpreting studies.
Author: Ramesh C. Gupta
Publisher: Academic Press
ISBN: 9780123820334
Category : Medical
Languages : en
Pages : 1220
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Book Description
Reproductive toxicology is a complex subject dealing with three components—parent, placenta, and fetus—and the continuous changes that occur in each. Reproductive and Developmental Toxicology is a comprehensive and authoritative resource providing the latest literature enriched with relevant references describing every aspect of this area of science. It addresses a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, food additives, nutraceuticals and pharmaceuticals, and metals, among others. With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages, and is the only resource to include reproductive and developmental toxicity in domestic animals, fish, and wildlife. Provides a complete, integrated source of information on the key risk stages during reproduction and development Includes coverage of emerging science such as stem cell application, toxicoproteomics, metabolomics, phthalates, infertility, teratogenicity, endocrine disruption, surveillance and regulatory considerations, and risk assessment Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis
Author: Ramesh C. Gupta
Publisher: Academic Press
ISBN: 0128042400
Category : Medical
Languages : en
Pages : 1460
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Book Description
Reproductive and Developmental Toxicology, Second Edition, is a comprehensive and authoritative resource that provides the latest literature on this complex subject with a primary focus on three core components—parent, placenta, and fetus—and the continuous changes that occur in each. Enriched with relevant references describing every aspect of reproductive toxicology, this revised and updated resource addresses the totality of the subject, discussing a broad range of topics, including nanoparticles and radiation, gases and solvents, smoking, alcohol and drug abuse, and metals, amongst others. With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages, also including discussions on reproductive and developmental toxicity in domestic animals, fish, and wildlife. Completely revised and updated to include the most recent developments in the field, the book is an essential resource for advanced students and researchers in toxicology, as well as biologists, pharmacologists, and teratologists from academia, industry, and regulatory agencies. Provides a complete, up-to-date, integrated source of information on the key risk stages during reproduction and development Includes new chapters covering significant developments, such as dose-response assessment for developmental toxicity, juvenile toxicity, and neural tube defects, as well as emerging science, such as stem cell application, toxicoproteomics, metabolomics, endocrine disruption, surveillance and regulatory considerations, and risk assessment Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis
Author: Ali S. Faqi
Publisher: Elsevier
ISBN: 0323984622
Category : Medical
Languages : en
Pages : 1074
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Book Description
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes 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 expectations associated with working in nonclinical toxicology
Author: Donald R. Mattison
Publisher: CRC Press
ISBN: 1439861080
Category : Medical
Languages : en
Pages : 330
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Book Description
Building from the perspective of reproductive and developmental biology, Computational Methods for Reproductive and Developmental Toxicology provides a timely and comprehensive overview of approaches in reproductive and developmental toxicology. The book, which is part of the QSAR in Environmental and Health Sciences series, is divided into three broad sections. The first provides a review of methods and approaches to meet the need for safety assessments in product development and regulatory approaches for environmental chemicals. The next one reviews the biological processes and endpoints involved in reproduction and development. The final and largest section summarizes protocols for evaluating biological processes and endpoints within reproduction and development. It also discusses informatics resources and computational methods. The book takes a cross-disciplinary approach bringing together developmental, reproductive and systems biology, chemistry, toxicology, pharmacology, biostatistics, information sciences, bioinformatics, and computational approaches. This valuable resource provides those in the field with the necessary knowledge to evaluate both classic and recent approaches to characterize toxicity.
Author: Nicolay Ferrari
Publisher: John Wiley & Sons
ISBN: 1118537335
Category : Medical
Languages : en
Pages : 576
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Book Description
A comprehensive review of contemporary antisense oligonucleotides drugs and therapeutic principles, methods, applications, and research Oligonucleotide-based drugs, in particular antisense oligonucleotides, are part of a growing number of pharmaceutical and biotech programs progressing to treat a wide range of indications including cancer, cardiovascular, neurodegenerative, neuromuscular, and respiratory diseases, as well as other severe and rare diseases. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide covering all key aspects of this increasingly popular area of pharmacology and biotech and pharma research, from the basic science behind antisense oligonucleotides chemistry, toxicology, manufacturing, to safety assessments, the design of therapeutic protocols, to clinical experience. Antisense oligonucleotides are single strands of DNA or RNA that are complementary to a chosen sequence. While the idea of antisense oligonucleotides to target single genes dates back to the 1970's, most advances have taken place in recent years. The increasing number of antisense oligonucleotide programs in clinical development is a testament to the progress and understanding of pharmacologic, pharmacokinetic, and toxicologic properties as well as improvement in the delivery of oligonucleotides. This valuable book reviews the fundamentals of oligonucleotides, with a focus on antisense oligonucleotide drugs, and reports on the latest research underway worldwide. • Helps readers understand antisense molecules and their targets, biochemistry, and toxicity mechanisms, roles in disease, and applications for safety and therapeutics • Examines the principles, practices, and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides • Provides guidelines for scientists in drug design and discovery to help improve efficiency, assessment, and the success of drug candidates • Includes interdisciplinary perspectives, from academia, industry, regulatory and from the fields of pharmacology, toxicology, biology, and medicinal chemistry Oligonucleotide-Based Drugs and Therapeutics belongs on the reference shelves of chemists, pharmaceutical scientists, chemical biologists, toxicologists and other scientists working in the pharmaceutical and biotechnology industries. It will also be a valuable resource for regulatory specialists and safety assessment professionals and an important reference for academic researchers and post-graduates interested in therapeutics, antisense therapy, and oligonucleotides.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070966
Category :
Languages : en
Pages : 10
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Book Description
The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed ...
Author: Ronald D Hood
Publisher: CRC Press
ISBN: 9781841847771
Category : Medical
Languages : en
Pages : 0
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Book Description
The purpose of this third edition of Developmental and Reproductive Toxicology is to provide a practical guide to developmental and reproductive toxicology in a regulatory environment. In addition to a comprehensive update of current chapters, the third edition been revised to reflect recent changes in the field. It contains new chapters that reflect emerging topics of interest, including testing of biologics (including vaccines), nonhuman primates as nonclinical models, developmental immunotoxicity testing, in vitro assays (such as use of zebrafish and stem cells, as well as high throughput screening), in silico systems modelling, evaluating mechanisms of reproductive toxicity, in-depth coverage of neurobehavioral testing, and testing under the EU’s REACH regulations, as well as updated chapters on nonclinical juvenile toxicity testing, endocrine disruptor screening, and on functional and computational genomics. The study of hazard and risk associated with exposure to toxicants during prenatal development has been expanded in recent years to include effects on development until the time of puberty. Concern over the adverse effects of chemical or physical agents on the reproductive processes of both sexes has increased, and progress has been made in identifying the causes and mechanisms eliciting congenital defects and determining the genetic, epigenetic, and environmental factors involved. This book provides up-to-date guidance on the use and interpretation of the newest research techniques in developmental and reproductive toxicology, as well as the more traditional approaches. Developmental and Reproductive Toxicology, Third Edition: Contains valuable insights gained from hands-on experience, together with a critical evaluation of current testing strategies. Includes guidance for the design, conduct, and interpretation of tests in all areas of developmental and reproductive toxicity. Contains reprinted guidelines from major regulatory agencies, as well as terminology for description of developmental abnormalities in laboratory animals, for easy reference. Provides guidance for planning and conducting preclinical toxicity studies and follow-up studies, and interpreting their results in a regulatory environment. This book continues to be the ideal practical reference for developmental and reproductive toxicologists who perform research in industry, government, and academia and for anyone who intends to enter these research areas.
Author: Ali S. Faqi
Publisher: Humana Press
ISBN: 9781493972067
Category : Medical
Languages : en
Pages : 314
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Book Description
This meticulous volume covers metabolism and drug-drug interactions during pregnancy, critical periods of developmental toxicology, in vivo and alternative methods to assess potential developmental toxicity for drugs and chemicals, and effects of chemicals on testes and mammary glands. Evaluation of developmental and reproductive toxicology endpoints is an integral part of the safety assessment process for compounds with potential use in women of childbearing age or females that might be exposed during pregnancy as well as men of reproductive potential. The in vivo assessments included here are guideline-driven and are required for submissions for product approval. Written for the Methods in Pharmacology and Toxicology series, this collection includes the kind of detailed implementation advice necessary for success in the lab. Authoritative and practical, Developmental and Reproductive Toxicology is an ideal resource for researchers working in this vital field of study./div
Author: National Research Council
Publisher: National Academies Press
ISBN: 9780309039796
Category : Social Science
Languages : en
Pages : 424
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Book Description
Does exposure to environmental toxicants inhibit our ability to have healthy children who develop normally? Biologic markersâ€"indicators that can tell us when environmental factors have caused a change at the cellular or biochemical level that might affect reproductive abilityâ€"are a promising tool for research aimed at answering that important question. Biologic Markers in Reproductive Toxicology examines the potential of these markers in environmental health studies; clarifies definitions, underlying concepts, and possible applications; and shows the benefits to be gained from their use in reproductive and neurodevelopmental research.
