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Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies
Interpretation and Relevance in Drug Safety Evaluation

by Peter Greaves

  • Publisher : Academic Press
  • Release : 2011-11-22
  • Pages : 886
  • ISBN : 0444538569
  • Language : En, Es, Fr & De
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Chapter 1: Introduction -- Chapter 2: Integumentary System -- -- Skin and subcutaneous tissue -- Chapter 3: Mammary Gland -- Chapter 4: Haemopoietic and Lymphatic Systems -- -- Blood/bone marrow -- -- Lymphoid system -- -- Lymph nodes -- -- Spleen -- -- Thymus -- -- Lymphoreticular neoplasms -- Chapter 5: Musculoskeletal System -- -- Bone -- -- Joints -- -- Skeletal muscle -- Chapter 6: Respiratory Tract -- -- Nose, nasal sinuses, nasopharynx and pharynx -- -- Larynx and trachea -- -- Bronchi and lungs -- Chapter 7: Cardiovascular System -- -- Heart and pericardium -- -- Systemic blood vessels -- -- Pulmonary blood vessels -- Chapter 8: Gastrointestinal tract -- -- Forestomach -- -- Stomach (glandular) -- -- Small intestine -- -- Large intestine -- Chapter 9: Liver and Pancreas -- -- Liver -- -- Bile ducts, biliary system -- -- Pancreas -- Chapter 10: Urinary System -- -- Kidney -- -- Urinary bladder -- Chapter 11: Male Genital Tract -- -- Prostate gland -- -- Epididymis -- -- Testis -- Chapter 12: Female Genital Tract -- -- Vagina -- -- Cervix -- -- Uterus -- -- Ovary -- Chapter 13: Endocrine System -- -- Pituitary gland -- -- Adrenal gland -- -- Thyroid gland -- -- Parathyroid gland -- Chapter 14: Nervous System and Special Sense Organs -- -- Brain -- -- Spinal cord, spinal nerve roots, peripheral nerves -- -- Eye -- -- Ear -- Subject index

Histopathology of Preclinical Toxicity Studies

Histopathology of Preclinical Toxicity Studies
Interpretation and Relevance in Drug Safety Evaluation

by Peter Greaves

  • Publisher : Elsevier Science Limited
  • Release : 1990
  • Pages : 824
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Histopathological assessment of tissue sections is an important componant of many preclinical studies which are conducted to support the safety and clinical development of novel therapeutic agents for use in the treatment of human diseases. The drug discovery process, aided by modern biotechnology, is now capable of generating highly potent, pharmacologically active agents which can give rise to quite unusual constellations of tissue pathology. The complexity and the number of histopathological findings in individual studies indicate the need for lucididy in descriptions and conclusions. In the light of these and other difficulties, this text is aimed towards bringing together into one volume a description of histopathological changes which relate to toxicity testing of therapeutic agents in the usual test species: rat, mouse, dog and non-human primate. This book is an excellent starting point for the analysis of drug-induced findings in toxicity studies.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
A Book

by Ali S. Faqi

  • Publisher : Academic Press
  • Release : 2012-11-16
  • Pages : 885
  • ISBN : 0123878152
  • Language : En, Es, Fr & De
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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
A Book

by Ali S. Faqi

  • Publisher : Academic Press
  • Release : 2016-11-03
  • Pages : 986
  • ISBN : 0128036214
  • Language : En, Es, Fr & De
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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

Background Lesions in Laboratory Animals E-Book

Background Lesions in Laboratory Animals E-Book
A Color Atlas

by Elizabeth Fiona McInnes

  • Publisher : Elsevier Health Sciences
  • Release : 2011-10-24
  • Pages : 256
  • ISBN : 0702049247
  • Language : En, Es, Fr & De
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Background Lesions in Laboratory Animals will be an invaluable aid to pathologists needing to recognize background and incidental lesions while examining slides taken from laboratory animals in acute and chronic toxicity studies, or while examining exotic species in a diagnostic laboratory. It gives clear descriptions and illustrations of the majority of background lesions likely to be encountered. Many of the lesions covered are unusual and can be mistaken for treatment-related findings in preclinical toxicity studies. The Atlas has been prepared with contributions from experienced toxicological pathologists who are specialists in each of the laboratory animal species covered and who have published extensively in these areas. over 600 high-definition, top-quality color photographs of background lesions found in rats, mice, dogs, minipigs, non-human primates, hamsters, guinea pigs and rabbits a separate chapter on lesions in the reproductive systems of all laboratory animals written by Dr Dianne Creasy, a world expert on testicular lesions in laboratory animals a chapter on common artifacts that may be observed in histological glass slides extensive references to each lesion described aging lesions encountered in all laboratory animal species, particularly in rats in mice which are used for carcinogenicity studies

The Illustrated Dictionary of Toxicologic Pathology and Safety Science

The Illustrated Dictionary of Toxicologic Pathology and Safety Science
A Book

by Pritam S. Sahota,Robert H. Spaet,Philip Bentley,Zbigniew Wojcinski

  • Publisher : CRC Press
  • Release : 2019-04-26
  • Pages : 672
  • ISBN : 0429658060
  • Language : En, Es, Fr & De
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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

Haschek and Rousseaux's Handbook of Toxicologic Pathology

Haschek and Rousseaux's Handbook of Toxicologic Pathology
A Book

by Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig

  • Publisher : Academic Press
  • Release : 2013-05-01
  • Pages : 3054
  • ISBN : 0124157653
  • Language : En, Es, Fr & De
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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

Biomarkers in Toxicology

Biomarkers in Toxicology
A Book

by Ramesh C. Gupta

  • Publisher : Academic Press
  • Release : 2019-02-13
  • Pages : 1246
  • ISBN : 0128146567
  • Language : En, Es, Fr & De
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Biomarkers in Toxicology, Second Edition, is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This revised and completely updated edition includes both vertebrate and non-vertebrate species models for toxicological testing and the development of biomarkers. Divided into several key sections, this reference volume contains new chapters devoted to topics in microplastics, neuroimmunotoxicity and nutraceuticals, along with a look at the latest cutting-edge technologies used to detect biomarkers. Each chapter contains several references to current literature and important resources for further reading. Given this comprehensive treatment, this book is an essential reference for anyone interested in biomarkers across the scientific and biomedical fields. Evaluates the expansive literature, providing one resource covering all aspects of toxicology biomarkers Includes completely revised chapters, along with additional chapters on the newest developments in the field Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation, and much more

Atlas of Experimental Toxicological Pathology

Atlas of Experimental Toxicological Pathology
A Book

by C. Gopinath,D. Prentice,D.J. Lewis

  • Publisher : Springer Science & Business Media
  • Release : 2012-12-06
  • Pages : 170
  • ISBN : 9400931891
  • Language : En, Es, Fr & De
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Our aim in producing a colour atlas of toxicological guidelines itemize the investigations to be carried out pathology was to present a catalogue of histopathologi during the course of the study and they normally include: cal lesions which we had encountered over the years in clinical observations and behaviour; food intake and body various laboratory animal species exposed to a vast weight measurements; serum biochemistry; haema range of pharmaceuticals, agrochemicals and industrial tology; ECG and ophthalmology. At the end of a study, chemicals. While we believe a colour atlas is the ideal full macroscopic and microscopic examinations of the way to share our experiences with others, it quickly organ weight analyses together with tissues are essen became clear to us that for the atlas to be meaningful tial. By far the greater part of the material used in this the associated text must be comprehensive and contain book is from toxicity studies conducted in recent years ample literature references. and performed in compliance with the Good Laboratory The atlas is intended for both the trainee and the Practice standards of governmental regulatory bodies in experienced toxicological pathologist working with lab Europe, Japan and North America. oratory animals in the pharmaceutical, agrochemical or Toxicity studies are commonly carried out in rats, chemical environment.

Drug Safety Evaluation

Drug Safety Evaluation
A Book

by Shayne Cox Gad

  • Publisher : John Wiley & Sons
  • Release : 2016-11-18
  • Pages : 918
  • ISBN : 1119097401
  • Language : En, Es, Fr & De
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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

Drug Discovery Toxicology

Drug Discovery Toxicology
From Target Assessment to Translational Biomarkers

by Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy

  • Publisher : John Wiley & Sons
  • Release : 2016-03-22
  • Pages : 584
  • ISBN : 1119053390
  • Language : En, Es, Fr & De
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As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Pathology for Toxicologists

Pathology for Toxicologists
Principles and Practices of Laboratory Animal Pathology for Study Personnel

by Elizabeth McInnes

  • Publisher : John Wiley & Sons
  • Release : 2017-05
  • Pages : 216
  • ISBN : 1118755413
  • Language : En, Es, Fr & De
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Non-pathologists, such as toxicologists and study personnel, can find it difficult to understand the data they receive from pathologists. Toxicological pathologists write long, detailed and highly technical reports. Study personnel are under daily pressure to decide whether lesions described in pathology reports are treatment-related and thus important to the pharmaceutical company or whether the lesions are background changes and thus of little significance. Written by experienced toxicological pathologists, Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study Personnel serves to bridge the gap in the understanding of pathology data, enabling non-pathologists to more easily comprehend pathology reports, better integrate pathology data into final study reports and ask pathologists relevant questions about the test compound. This succinct, fully referenced, full colour book is suitable for toxicologists at all stages of their training or career who want to know more about the pathology encountered in laboratory animals used in safety studies. Key features include important chapters on spontaneous and target organ lesions in rats, mice, non-human primates, mini pigs, rabbits and beagle dogs as well as information on general pathology, macroscopic target organ lesions, ancillary pathology techniques, haematology, biochemistry and adversity. Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study Personnel includes: Colour diagrams explaining how lesions are caused by either external compounds or spontaneously The anatomic variations and background lesions of laboratory animals Advice on sampling tissues, necropsy, ancillary pathology techniques and recording data A chapter on the haematology and biochemistry of laboratory animals Full colour photographs of common macroscopic lesions encountered in laboratory animals A comprehensive glossary

Infant Formula

Infant Formula
Evaluating the Safety of New Ingredients

by Institute of Medicine,Food and Nutrition Board,Committee on the Evaluation of the Addition of Ingredients New to Infant Formula

  • Publisher : National Academies Press
  • Release : 2004-07-10
  • Pages : 220
  • ISBN : 0309091500
  • Language : En, Es, Fr & De
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Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.

OECD Guidelines for Testing of Chemicals

OECD Guidelines for Testing of Chemicals
A Book

by Organisation for Economic Co-operation and Development

  • Publisher : Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
  • Release : 1981
  • Pages : 329
  • ISBN : 9789264122215
  • Language : En, Es, Fr & De
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Cryopreservation Biotechnology in Biomedical and Biological Sciences

Cryopreservation Biotechnology in Biomedical and Biological Sciences
A Book

by Yusuf Bozkurt

  • Publisher : BoD – Books on Demand
  • Release : 2018-12-12
  • Pages : 152
  • ISBN : 1789846803
  • Language : En, Es, Fr & De
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Cryopreservation has many biotechnological applications in different fields. This has led to an increase in importance of cryobiology as a science that examines the effect of ultra-low temperatures on cells, tissues, organs and organisms and also the freezability of these structures, while maintaining their viability. Nowadays it is well known that this form of biotechnology can be used to solve a lot of problems such as human infertility, life threatening diseases, preservation of gametes and DNA and also biodiversity conservation. Cryopreservation Biotechnology in Biomedical and Biological Sciences describes principles and application of cryopreservation biotechnology in different research areas and includes seven chapters that have been written by experts in their research fields. The chapters included in this book are thought to improve the current understanding of the different areas of using cryopreservation biotechnology.

Toxicology

Toxicology
New Aspects to This Scientific Conundrum

by Marcelo Larramendy,Sonia Soloneski

  • Publisher : BoD – Books on Demand
  • Release : 2016-10-26
  • Pages : 218
  • ISBN : 9535127160
  • Language : En, Es, Fr & De
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This edited book, Toxicology - New Aspects to This Scientific Conundrum, is intended to provide an overview on the different xenobiotics employed every day in our anthropogenic activities. We hope that this book will continue to meet the expectations and needs of all interested in the implications for the living species of known and new toxicants and to guide them in the future investigations.

Research Methods for Public Health

Research Methods for Public Health
A Book

by Stuart McClean,Issy Bray,Nick de Viggiani,Emma Bird,Paul Pilkington

  • Publisher : SAGE
  • Release : 2019-09-30
  • Pages : 296
  • ISBN : 1526485524
  • Language : En, Es, Fr & De
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Research Methods for Public Health offers an in-depth introduction to the theories, concepts, approaches and practices, relevant to research methods in a public health setting. Informed by a socio-ecological model of public health, the book uses real world research examples and contemporary social, political and environmental themes of public health that reflect UK and international contexts. The book provides a straightforward approach to developing a research project and applying methods in practical and realistic ways, using an innovative, integrative approach that combines methodologies. The authors have moved away from traditional approaches to research methods, and include chapters on primary quantitative, qualitative and mixed methods research, evidence synthesis approaches, critical appraisal, research governance and ethics, and dissemination. Essential reading for postgraduate students, researchers and public health practitioners, or individuals preparing for the UK Faculty of Public Health Part A examination.

Drug Safety Evaluation

Drug Safety Evaluation
Methods and Protocols

by Jean-Charles Gautier

  • Publisher : Humana Press
  • Release : 2010-10-28
  • Pages : 431
  • ISBN : 9781603271868
  • Language : En, Es, Fr & De
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Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular BiologyTM series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.

Regulatory Toxicology

Regulatory Toxicology
A Book

by MICHAEL SCHWENK. FRANZ-XAVER REICHL

  • Publisher : Unknown Publisher
  • Release : 2019
  • Pages : 329
  • ISBN : 9783642362064
  • Language : En, Es, Fr & De
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Drug-Induced Liver Disease

Drug-Induced Liver Disease
A Book

by Neil Kaplowitz

  • Publisher : CRC Press
  • Release : 2002-10-16
  • Pages : 784
  • ISBN : 0203909127
  • Language : En, Es, Fr & De
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Featuring more than 4100 references, Drug-Induced Liver Disease will be an invaluable reference for gastroenterologists, hepatologists, family physicians, internists, pathologists, pharmacists, pharmacologists, and clinical toxicologists, and graduate and medical school students in these disciplines.