The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

Author : Joerg Bluemel
Publisher : Academic Press
ISBN 13 : 012417146X
Total Pages : 716 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by : Joerg Bluemel

Download or read book The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment written by Joerg Bluemel and published by Academic Press. This book was released on 2015-03-13 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

Challenges in Nonhuman Primate Research in the 21st Century

Author : Gerhard F. Weinbauer
Publisher : Waxmann Verlag
ISBN 13 : 3830978391
Total Pages : 180 pages
Book Rating : 4.8/5 (39 download)

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Book Synopsis Challenges in Nonhuman Primate Research in the 21st Century by : Gerhard F. Weinbauer

Download or read book Challenges in Nonhuman Primate Research in the 21st Century written by Gerhard F. Weinbauer and published by Waxmann Verlag. This book was released on 2013 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Nonclinical Safety Assessment

Author : William J. Brock
Publisher : John Wiley & Sons
ISBN 13 : 1118516982
Total Pages : 492 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Nonclinical Safety Assessment by : William J. Brock

Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-03-05 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations 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.

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Author : Carrie Markgraf
Publisher : Academic Press
ISBN 13 : 0124202160
Total Pages : 320 pages
Book Rating : 4.1/5 (242 download)

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Book Synopsis Nonclinical Assessment of Abuse Potential for New Pharmaceuticals by : Carrie Markgraf

Download or read book Nonclinical Assessment of Abuse Potential for New Pharmaceuticals written by Carrie Markgraf and published by Academic Press. This book was released on 2015-07-14 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy

Drug Safety Evaluation

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0471459291
Total Pages : 1020 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2003-09-05 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

Drug Safety Evaluation

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 111909741X
Total Pages : 918 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-12-01 with total page 918 pages. Available in PDF, EPUB and Kindle. 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

Toxicologic Pathology

Author : Pritam S. Sahota
Publisher : CRC Press
ISBN 13 : 1439872120
Total Pages : 987 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Toxicologic Pathology by : Pritam S. Sahota

Download or read book Toxicologic Pathology written by Pritam S. Sahota and published by CRC Press. This book was released on 2013-04-09 with total page 987 pages. Available in PDF, EPUB and Kindle. Book excerpt: As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical drug research, Toxicologic Pathology: Nonclinical Saf

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Author : H.Gerhard Vogel
Publisher : Springer Science & Business Media
ISBN 13 : 3540898905
Total Pages : 576 pages
Book Rating : 4.5/5 (48 download)

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Book Synopsis Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel

Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Drug Safety Evaluation

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 1119755859
Total Pages : 996 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2023-01-12 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

Advanced Issue Resolution in Safety Pharmacology

Author : Mary Jeanne Kallman
Publisher : Academic Press
ISBN 13 : 9780128122068
Total Pages : 0 pages
Book Rating : 4.1/5 (22 download)

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Book Synopsis Advanced Issue Resolution in Safety Pharmacology by : Mary Jeanne Kallman

Download or read book Advanced Issue Resolution in Safety Pharmacology written by Mary Jeanne Kallman and published by Academic Press. This book was released on 2018-09-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

Nonhuman Primate Models in Preclinical Research

Author : Huifang Chen
Publisher :
ISBN 13 : 9781536194401
Total Pages : 0 pages
Book Rating : 4.1/5 (944 download)

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Book Synopsis Nonhuman Primate Models in Preclinical Research by : Huifang Chen

Download or read book Nonhuman Primate Models in Preclinical Research written by Huifang Chen and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Due to the phylogenetic relationship and close genetic and biological similarities with humans, non-human primates (NHP) are regularly used in biomedical and behavioural research. However, because of their highly developed cognitive abilities and social skills, the use of these animals in biomedical research is debated more and more. Although it is acknowledged that in specific research areas NHP are still essential, it is recognized that the use of these animals can only be done under strict conditions under the most optimal welfare aspects. Welfare aspects include housing conditions, non-invasive methods and application of the 3Rs policy. Although many refinement methods have been described in nationally and internationally accepted guidelines on animal laboratory practice, recognition of the guidelines is unfortunately not universal. The present book covers a wide range of NHP models in preclinical research and welfare issues. The following chapters will cover: refinement of the use of NHP in biomedical research; NHP ethics and regulations in Europe; biological basis differences in the human and NHP; the major histocompatibility complex (MHC) immunology in NHP; stem cell biology in NHP; neuro and gliogenesis in an NHP ischemia stroke model; NHP models in autoimmune disease, organ transplantation and infectious disease research; viral diseases in NHP; NHP models in Parkinson's disease, in neurodegenerative disorders research and in cardio-cerebrovascular disease research; islet transplantation; ophthalmic diseases research and neurophysiology in NHP; transgenic engineering in NHP; NHP models of cancers; NHP models in respiratory disease research; NHP models in clinical and non-clinical pharmacology; NHP models in lung transplantation; and aging research in NHP. This book encapsulates a large volume of knowledge scientists have achieved in the field of nonhuman primate models in preclinical research. The editors have invited experts from the United States, Canada, and Europe to contribute 23 chapters in their respective fields of their expertise"--

Spontaneous Pathology of the Laboratory Non-human Primate

Author : Alys Bradley
Publisher : Academic Press
ISBN 13 : 012813089X
Total Pages : 628 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Spontaneous Pathology of the Laboratory Non-human Primate by : Alys Bradley

Download or read book Spontaneous Pathology of the Laboratory Non-human Primate written by Alys Bradley and published by Academic Press. This book was released on 2023-06-20 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spontaneous Pathology of the Laboratory Non-human Primate serves as a "go to" resource for all pathologists working on primates in safety assessment studies. In addition, it helps diagnostic veterinary pathologists rule out spontaneous non-clinical disease pathologies when assigning cause of death to species in zoological collections. Primate species included are rhesus, cynomolgus macaques and marmosets. Multi-authored chapters are arranged by organ system, thus providing the necessary information for continued research.Pathologists often face a lack of suitable reference materials or historical data to determine if pathologic changes they are observing in monkeys are spontaneous or a consequence of other treatments or factors. Contains color illustrations that depict the most common lesions to augment descriptions Covers descriptions that are compliant with the International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) guidelines set forth by the Society of Toxicologic Pathology (STP) Provides pathologists with common terms that are compliant with the FDA’s Standard for Exchange of Nonclinical Data (SEND) guidelines

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Author : Ali S. Faqi
Publisher : Elsevier
ISBN 13 : 0323857043
Total Pages : 1072 pages
Book Rating : 4.3/5 (238 download)

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Book Synopsis A Comprehensive Guide to Toxicology in Nonclinical Drug Development by : Ali S. Faqi

Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Elsevier. This book was released on 2024-02-20 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Nonhuman Primates in Biomedical Research

Author : Christian R. Abee
Publisher : Academic Press
ISBN 13 : 0123978386
Total Pages : 868 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Nonhuman Primates in Biomedical Research by : Christian R. Abee

Download or read book Nonhuman Primates in Biomedical Research written by Christian R. Abee and published by Academic Press. This book was released on 2012-06-07 with total page 868 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 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. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in bioledical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information Includes four color images throughout

Veterinary Cytology

Author : Leslie C. Sharkey
Publisher : John Wiley & Sons
ISBN 13 : 1119125715
Total Pages : 2168 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Veterinary Cytology by : Leslie C. Sharkey

Download or read book Veterinary Cytology written by Leslie C. Sharkey and published by John Wiley & Sons. This book was released on 2020-08-11 with total page 2168 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a state-of-the-art, evidence-based reference to all aspects of veterinary cytology. Truly multidisciplinary in its approach, chapters are written by experts in fields ranging from clinical pathology to internal medicine, surgery, ophthalmology, and dermatology, drawing the various specialties together to create a comprehensive picture of cytology's role in diagnosis and treatment of animal disease. Firmly grounded in the primary literature, the book focuses on companion animals, with special chapters for species with fewer publications. Chapters are logically organized by body system, with additional chapters on tumors of particular import and diagnostic decision making. The first two sections of Veterinary Cytology focus on cytology techniques, quality control, and special laboratory techniques. Subsequent sections are organ/tissue-based and reflect what is known about the canine, feline, and equine species. This is followed by chapters on non-traditional species, including exotic companion mammals, rabbits, cattle, camelids, non-human primates, reptiles and birds, amphibians, fish, invertebrates, and sheep and goats. The last section highlights some unique features of the applications of cytology in industry settings. Provides a gold-standard reference to data-driven information about cytologic analysis in companion animal species Brings together authors from a wide range of specialties to present a thorough survey of cytology's use in veterinary medicine Offers broader species coverage and greater depth than any cytology reference currently available Veterinary Cytology is an essential resource for clinical and anatomic pathologists and any specialist in areas using cytology, including veterinary oncologists, criticalists, surgeons, ophthalmologists, dermatologists, and internists.

Toxicokinetics

Author :
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Toxicokinetics by :

Download or read book Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 481 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.