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Hands-On Approach for the Conduct of Nonclinical Studies

Hands-On Approach for the Conduct of Nonclinical Studies
A Manual for Anticipating and Avoiding Potential Problems

by Deven Dandekar,Pallavi B. Limaye

  • Publisher : Academic Press
  • Release : 2019-03
  • Pages : 365
  • ISBN : 9780128131008
  • Language : En, Es, Fr & De
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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

Targeted Therapy in Translational Cancer Research

Targeted Therapy in Translational Cancer Research
A Book

by Apostolia-Maria Tsimberidou,Razelle Kurzrock,Kenneth C. Anderson

  • Publisher : John Wiley & Sons
  • Release : 2015-10-08
  • Pages : 320
  • ISBN : 1118468686
  • Language : En, Es, Fr & De
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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

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
A Guide for Non-Clinical Development

by Alberto Lodola,Jeanne Stadler

  • Publisher : John Wiley & Sons
  • Release : 2011-02-07
  • Pages : 276
  • ISBN : 9780470371374
  • Language : En, Es, Fr & De
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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.

Nonhuman Primates in Biomedical Research

Nonhuman Primates in Biomedical Research
Biology and Management

by Christian R. Abee,Keith Mansfield,Suzette D. Tardif,Timothy Morris

  • Publisher : Academic Press
  • Release : 2012-05-09
  • Pages : 536
  • ISBN : 0123978378
  • Language : En, Es, Fr & De
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The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information

Global Approach in Safety Testing

Global Approach in Safety Testing
ICH Guidelines Explained

by Jan Willem van der Laan,Joseph J DeGeorge

  • Publisher : Springer Science & Business Media
  • Release : 2013-02-11
  • Pages : 315
  • ISBN : 1461459508
  • Language : En, Es, Fr & De
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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”.

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

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

by William J. Brock,Barbara Mounho,Lijie Fu

  • Publisher : John Wiley & Sons
  • Release : 2014-05-02
  • Pages : 560
  • ISBN : 1118874080
  • Language : En, Es, Fr & De
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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
A Book

by Sarfaraz K. Niazi

  • Publisher : CRC Press
  • Release : 2014-10-29
  • Pages : 1007
  • ISBN : 1482226383
  • Language : En, Es, Fr & De
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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

Nonclinical Safety Assessment

Nonclinical Safety Assessment
A Guide to International Pharmaceutical Regulations

by William J. Brock,Kenneth L. Hastings,Kathy M. McGown

  • Publisher : John Wiley & Sons
  • Release : 2013-03-05
  • Pages : 488
  • ISBN : 1118516982
  • Language : En, Es, Fr & De
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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.

Fundamentals of Pharmaceutical Nanoscience

Fundamentals of Pharmaceutical Nanoscience
A Book

by Ijeoma F. Uchegbu,Andreas G. Schätzlein,Woei Ping Cheng,Aikaterini Lalatsa

  • Publisher : Springer Science & Business Media
  • Release : 2013-11-23
  • Pages : 598
  • ISBN : 1461491649
  • Language : En, Es, Fr & De
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Nanoscience or the science of the very small offers the pharmaceutical scientist a wealth of opportunities. By fabricating at the nanoscale, it is possible to exert unprecedented control on drug activity. This textbook will showcase a variety of nanosystems working from their design and construction to their application in the field of drug delivery. The book is intended for graduate students in drug delivery, physical and polymer chemistry, and applied pharmaceutical sciences courses that involve fundamental nanoscience. The purpose of the text is to present physicochemical and biomedical properties of synthetic polymers with an emphasis on their application in polymer therapeutics i.e., pharmaceutical nanosystems, drug delivery and biological performance. There are two main objectives of this text. The first is to provide advanced graduate students with knowledge of the principles of nanosystems and polymer science including synthesis, structure, and characterization of solution and solid state properties. The second is to describe the fundamentals of therapeutic applications of polymers in drug delivery, targeting, response modifiers as well as regulatory issues. The courses, often listed as Advanced Drug Delivery and Applied Pharmaceutics; Polymer Therapeutics; or Nanomedicine, are designed as an overview of the field specifically for graduate students in the Department of Pharmaceutical Sciences Graduate Programs. However, the course content may also be of interest for graduate students in related biomedical research programs. These courses generally include a discussion of the major principles of polymer science and fundamental concepts of application of polymers as modern therapeutics. All courses are moving away from the above mentioned course names and going by ‘pharmaceutical nanoscience or nanosystems’. This area of research and technology development has attracted tremendous attention during the last two decades and it is expected that it will continue to grow in importance. However, the area is just emerging and courses are limited but they are offered.

Side Effects of Drugs Annual

Side Effects of Drugs Annual
A Worldwide Yearly Survey of New Data and Trends in Adverse Drug Reactions

by Jeffrey K. Aronson

  • Publisher : Elsevier
  • Release : 2010-11-18
  • Pages : 1056
  • ISBN : 9780444535511
  • Language : En, Es, Fr & De
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The Side Effects of Drugs Annual was first published in 1977. It has been continually published since then, as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs. Each new Annual continues to provide clinicians and medical investigators with a reliable and critical yearly survey of new data and trends in the area of Adverse Drug Reactions and Interactions. An international team of specialists has contributed to the informative, by critically interpreting it, and by pointing to whatever is misleading. Provides a critical yearly survey of new data and trends Special reviews in this Annual include, among other topics, Epidemiology of the use of ecstasy, Paracetamol and the risk of asthma, Combination vaccines/multiple immunizations, Interactions of herbal medicines with warfarin, and Tyrosine kinase inhibitors

Gene Therapy of Cancer

Gene Therapy of Cancer
Translational Approaches from Preclinical Studies to Clinical Implementation

by Edmund C. Lattime,Stanton L. Gerson

  • Publisher : Academic Press
  • Release : 2013-08-28
  • Pages : 554
  • ISBN : 0123946328
  • Language : En, Es, Fr & De
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Gene therapy as a treatment for cancer is at a critical point in its evolution. Exciting new developments in gene targeting and vector technology, coupled with results from the first generation of preclinical and clinical studies have led to the design and testing of new therapeutic approaches. The Third Edition of Gene Therapy of Cancer provides crucial updates on the basic and applied sciences of gene therapy. It offers a comprehensive assessment of the field including the areas of suicide gene therapy, oncogene and suppressor gene targeting, immunotherapy, drug resistance gene therapy, and the genetic modification of stem cells. Researchers at all levels of development, from basic laboratory investigators to clinical practitioners, will find this book to be instructive. Cancer gene therapy, like cancer therapy in general, is evolving rapidly, testing new concepts, targets and pathways, evoking new technologies, and passing new regulatory hurdles. Its essence, however, has not changed: the hope and challenges of returning altered genes to normal, using targeted gene expression to alter the function of both tumor and microenvironment, and in some cases normal cells, and delivering functionally important genes to specific cell types to increase sensitivity to killing or to protect normal cells from cancer therapies. In some instances, gene therapy for cancer forms a continuum from gene repair through the use of molecularly modified cells; the use of viral and non-viral vector based gene delivery to both tumor and tumor microenvironment; the use of viral and gene based vaccines; and development of new gene-based therapeutics. The unique mechanistically chosen vector platforms are at the heart of this technology because they allow for direct and selective cell death and transient to sustained delivery of vaccine molecules or molecules that affect the microenvironment, vasculature, or the immune response. Explains the underlying cancer biology necessary for understanding proposed therapeutic approaches Presents in-depth description of targeting systems and treatment strategies Covers the breadth of gene therapy approaches including immunotherapeutic, drug resistance,oncolytic viruses, as well as regulatory perspectives from both the NCI and FDA

Nonhuman Primates in Biomedical Research,Two Volume Set

Nonhuman Primates in Biomedical Research,Two Volume Set
A Book

by Christian R. Abee,Keith Mansfield,Suzette D. Tardif,Timothy Morris

  • Publisher : Academic Press
  • Release : 2012-12-31
  • Pages : 1200
  • ISBN : 0124159729
  • Language : En, Es, Fr & De
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The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The publication emphasizes the biology and management, diseases, and biomedical models for nonhuman primate species most commonly used in research. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. The Diseases volume provides thorough reviews of naturally occurring diseases of nonhuman primates, with a section on biomedical models reviewing contemporary nonhuman primate models of human diseases. Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information

Advances in Clinical Child Psychology

Advances in Clinical Child Psychology
A Book

by Benjamin Lahey

  • Publisher : Springer Science & Business Media
  • Release : 2012-12-06
  • Pages : 326
  • ISBN : 1461398207
  • Language : En, Es, Fr & De
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A decade ago, Advances in Clinical Child Psychology was conceived to provide approximately annual updates on the forward edge of research and practice in this rapidly growing field. A look back at the 56 chapters published in previous volumes provides a broad overview of the direc tion of advancement in clinical child psychology, at least as viewed by one collection of editors, consulting editors, and authors. The trends are clear: There have been decreasing numbers of advances in modes and methods of therapy, an increasing emphasis on the family, a renewed interest in experimental psychopathology (studies of classification, etiol ogy, and prognosis), a growing rapprochement between biological and psychological perspectives, and continued strong interest in cognition and social relationships. The current volume clearly shows these directions in the growth of the field. One chapter discusses etiology, four are concerned with the psychopathology of specific diagnostic categories, one takes an ex panded cognitive approach to social competence, and two look at the family system by examining the effects of male parents and children on other members of the family. A final chapter opens discussion on the important topic of the nature of excellence in the training of clinical child psychologists. It is hoped that this chapter will initiate a national di alogue on this multifaceted and often neglected topic.

New Scientist

New Scientist
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2000
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters
Concepts, Methods and Translational Sciences

by Shuguang Ma,Swapan Chowdhury

  • Publisher : Elsevier
  • Release : 2020-07-09
  • Pages : 708
  • ISBN : 0128200197
  • Language : En, Es, Fr & De
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Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade’s numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics All chapters are written by experts with a wide range of practical experience from the industry and academia

Challenges in Nonhuman Primate Research in the 21st Century

Challenges in Nonhuman Primate Research in the 21st Century
A Book

by Gerhard F. Weinbauer,Friedhelm Vogel

  • Publisher : Waxmann Verlag
  • Release : 2013
  • Pages : 180
  • ISBN : 3830978391
  • Language : En, Es, Fr & De
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In continuation of the Covance Primate Symposium Series, the 19th Covance Primate Symposium took place in Münster on 23rd & 24th of May 2012. Altogether, 70 participants representing 43 organisations, gathered for this symposium. The 2012 Primate Symposium focussed on ?Challenges in Nonhuman Primate Research in the 21st Century?. The broad participation and the lively discussions during the symposium underlined the timeliness and importance of this topic. Expert speakers covered four major topics, i.e. biosimilars development: regulatory implications, key considerations and next steps, optimizing nonhuman primate use in nonclinical safety assessment, trends in nonhuman primate developmental & reproductive toxicology (DART) and juvenile toxicity evaluation, and relevance and importance of nonhuman primate models in regulatory toxicology. The development of biosimilar has taken up speed considerably and meanwhile needs to be considered a significant factor of potential drug development, yet there are still some uncertainties und guidelines are under development. With the increased focus on biopharmaceuticals and the associated increase for using nonhuman primates being the relevant animal model, it became necessary to optimize the use of this animal model, e.g. refine study designs and animals numbers but still execute meaningful preclinical studies. It appears that significant progress has been achieved in that context. In the area of nonhuman primate DART and juvenile toxicity evaluation, recent guideline changes had a major impact on species selection, and the experimental design plus the timing of these studies within the preclinical programmes. Finally, given the increasing regulations and justficiations of using nonhuman primates as experimental models. It is paramount to understand the essential and indispensable role that nonhuman primates can play in drug safety evaluation and medical drug development.

Handbook of LC-MS Bioanalysis

Handbook of LC-MS Bioanalysis
Best Practices, Experimental Protocols, and Regulations

by Wenkui Li,Jie Zhang,Francis L. S. Tse

  • Publisher : John Wiley & Sons
  • Release : 2013-09-03
  • Pages : 704
  • ISBN : 111867135X
  • Language : En, Es, Fr & De
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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.

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

Principles of Research Data Audit

Principles of Research Data Audit
A Book

by Adil E. Shamoo

  • Publisher : Taylor & Francis
  • Release : 1989
  • Pages : 181
  • ISBN : 9782881243783
  • Language : En, Es, Fr & De
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First published in 1989. Routledge is an imprint of Taylor & Francis, an informa company.