Safety Evaluation Of Biotechnologically Derived Pharmaceuticals

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Safety Evaluation of Biotechnologically-derived Pharmaceuticals

Author : Susan A. Griffiths
Publisher : Springer Science & Business Media
ISBN 13 : 9401148767
Total Pages : 208 pages
Book Rating : 4.4/5 (11 download)

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Book Synopsis Safety Evaluation of Biotechnologically-derived Pharmaceuticals by : Susan A. Griffiths

Download or read book Safety Evaluation of Biotechnologically-derived Pharmaceuticals written by Susan A. Griffiths and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline `Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.

Guidance for industry

Author :
Publisher :
ISBN 13 :
Total Pages : 11 pages
Book Rating : 4.:/5 (422 download)

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Book Synopsis Guidance for industry by :

Download or read book Guidance for industry written by and published by . This book was released on 1997 with total page 11 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Addendum to ICH S6

Author :
Publisher :
ISBN 13 :
Total Pages : 14 pages
Book Rating : 4.:/5 (493 download)

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Book Synopsis Addendum to ICH S6 by :

Download or read book Addendum to ICH S6 written by and published by . This book was released on 2009 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Preclinical Safety Evaluation of Biopharmaceuticals

Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
ISBN 13 : 1118679385
Total Pages : 1012 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Preclinical Safety Evaluation of Biopharmaceuticals by : Joy A. Cavagnaro

Download or read book Preclinical Safety Evaluation of Biopharmaceuticals written by Joy A. Cavagnaro and published by John Wiley & Sons. This book was released on 2013-03-07 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.

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.

Biotechnology And Safety Assessment

Author : John A. Thomas
Publisher : CRC Press
ISBN 13 : 9780781700801
Total Pages : 296 pages
Book Rating : 4.7/5 (8 download)

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Book Synopsis Biotechnology And Safety Assessment by : John A. Thomas

Download or read book Biotechnology And Safety Assessment written by John A. Thomas and published by CRC Press. This book was released on 1993-06-30 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, experts from academe, industry, and public health institutes discuss the issues involved in toxicology evaluation, safety assessment, and regulation of biotechnology-derived drugs, foods, and plant products. Coverage includes recombinant DNA agents, monoclonal antibodies, recombinant hormones and other proteins, biotechnology-derived drug delivery systems, gene therapy for genetic diseases, and genetically engineered plants and plant products. Full consideration is given to key methodological issues in product development and testing, such as use of "in vitro" and "in vivo" toxicology tests, choice of animal models, and use of transgenic animal models and genetically altered species to study human diseases. The book includes an appendix describing available animal models and a glossary of terms, definitions, and acronyms.

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.

Safety Evaluation of Pharmaceuticals and Medical Devices

Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 1441974490
Total Pages : 126 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Safety Evaluation of Pharmaceuticals and Medical Devices by : Shayne C. Gad

Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.

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.

Pharmaceutical Biotechnology

Author : Gary Walsh
Publisher : John Wiley & Sons
ISBN 13 : 111868575X
Total Pages : 499 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Pharmaceutical Biotechnology by : Gary Walsh

Download or read book Pharmaceutical Biotechnology written by Gary Walsh and published by John Wiley & Sons. This book was released on 2013-04-25 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

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.

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.

Physiology Or Medicine

Author : Jan Lindsten
Publisher : World Scientific
ISBN 13 : 9789810207915
Total Pages : 682 pages
Book Rating : 4.2/5 (79 download)

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Book Synopsis Physiology Or Medicine by : Jan Lindsten

Download or read book Physiology Or Medicine written by Jan Lindsten and published by World Scientific. This book was released on 1992 with total page 682 pages. Available in PDF, EPUB and Kindle. Book excerpt: The quality of life for millions of people all over the globe has been improved by the work of diligent biologists and doctors working in the many branches of life science. An improved knowledge of how the body functions at the genetic, cellular, physiological and behavioural levels and a greater understanding of disease and pharmacology have resulted in a reduction in human suffering. The way is being paved for the effective treatment of some of the greatest health problems of the late twentieth century ? cancer, AIDS and diseases caused by parasites.These two volumes are collections of the Nobel Lectures delivered by the laureates, together with their biographies, portraits and the presentation speeches for the periods 1971 ? 1980 and 1981 ? 1990 respectively. Each Nobel Lecture is based on the work for which the laureate was awarded the prize. New biographical data of the laureate are also included. These volumes of inspiring lectures by outstanding scientists should be on the bookshelf of every keen student, teacher and professor of biological and medical sciences as well as of those in related fields.During the period 1971 ? 1980 important areas of research being recognized were as diverse as hormone action and radioimmunoassays, infectious diseases, molecular genetics, immunology, computerized tomography and social behaviour. The laureates according to the specific year are: (1971) E W SUTHERLAND JR ? for his discoveries concerning the mechanisms of the action of hormones; (1972) G M EDELMAN & R R PORTER ? for their discoveries concerning the chemical structure of antibodies; (1973) K VON FRISCH, K LORENZ & N TINBERGEN ? for their discoveries concerning organization and elicitation of individual and social behaviour patterns; (1974) A CLAUDE, C DE DUVE & G E PALADE ? for their discoveries concerning the structural and functional organization of the cell; (1975) D BALTIMORE, R DULBECCO & H M TEMIN ? for their discoveries concerning the interaction between tumour viruses and genetic material of the cell; (1976) B S BLUMBERG & D C GAJDUSEK ? for their discoveries concerning new mechanisms for the origin and dissemination of infectious diseases; (1977) R GUILLEMIN & A V SCHALLY ? for their discoveries concerning the peptide hormone production of the brain; and R S YALOW ? for the development of radioimmunoassays of peptide hormones; (1978) W ARBER, D NATHANS & H O SMITH ? for the discovery of restriction enzymes and their application to problems of molecular genetics; (1979) A M CORMACK & G N HOUNSFIELD ? for the development of computer assisted tomography; (1980) B BENACERRAF, J DAUSSET & G D SNELL ? for their discoveries concerning genetically determined structures on the cell surface that regulate immunological reactions.

Safety Evaluation of Natural Products in Biotechnology

Author : Vivek Kothari
Publisher : Gene-Tech Books
ISBN 13 : 9788189729141
Total Pages : 0 pages
Book Rating : 4.7/5 (291 download)

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Book Synopsis Safety Evaluation of Natural Products in Biotechnology by : Vivek Kothari

Download or read book Safety Evaluation of Natural Products in Biotechnology written by Vivek Kothari and published by Gene-Tech Books. This book was released on 2007-02-24 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Introduction Of Biotechnology In Every Aspect Of Natural Products Research, Has Dramatically Facilitated The Potential Applications By The Industry Today. Natural Dyes, Alternative Food Ingredients And Preservation Materials And Microbial Polysaccharides, Are Only Some Examples Of The Growing Use Of Natural Products In The Industry. Importantly, The Pharmaceutical Sector Is Actively Involved In Natural Products Research, Since A Large Number Of Novel Compounds Have Medicinal Value. Although Natural Products Has The Chemical Diversity And Has Been Proven To Be Useful Templates, Their Sustainable Supply From The Original Biological Source Always Remain A Problem. Biotechnology Is Expected To Play A Major Role In The Production Of Natural Products Through Biosynthesis And Bioengineering Which Will Further Reduce The Dependence On A Large Amount Of Plant Samples And Hence Reduce The Pressure Of Reducing The Number Of Biogenetic Resources In The Tropical Forests. This Book Describes The Importance Of Biotechnology In The Search For Natural Products From Plants And Other Sources. It Aims To Provide Readers With A Comprehensive Information Which Will Help Them To Successfully Address Current Research And Application Issues In Natural Products And Biotechnology. Contents Chapter 1: Introduction To Natural Products; Chapter 2: Natural Products And Drug Discovery; Chapter 3: Genetic Manipulation And Natural Products; Chapter 4: Bioprocessing And Natural Products; Chapter 5: Enzyme Technology In Food Processing; Chapter 6: Biotechnology And Marine Natural Products; Chapter 7: Safety Evaluation Of Biotechnology Products Derived From Animals; Chapter 8: Medicinal Natural Products And Risk Assessment; Chapter 9: Safety Testing Of Medicinal Products Derived From Biotechnology; Chapter 10: Safety Evaluation Of Natural Food Products.

Stephens' Detection and Evaluation of Adverse Drug Reactions

Author : John Talbot
Publisher : John Wiley & Sons
ISBN 13 : 0470986344
Total Pages : 751 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Stephens' Detection and Evaluation of Adverse Drug Reactions by : John Talbot

Download or read book Stephens' Detection and Evaluation of Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2011-12-19 with total page 751 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written with practitioners in mind, this new edition of Stephen’s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.

Biotechnology and Safety Assessment

Author : John A. Thomas
Publisher : Elsevier
ISBN 13 : 9780080528182
Total Pages : 400 pages
Book Rating : 4.5/5 (281 download)

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Book Synopsis Biotechnology and Safety Assessment by : John A. Thomas

Download or read book Biotechnology and Safety Assessment written by John A. Thomas and published by Elsevier. This book was released on 2002-09-05 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive treatise on new developments in biotechnology, the authors of Biotechnology and Safety Assessment, 3e, bring readers an up-to-date review of food safety issues, pre-clinical safety and development of new foods and drugs, plant biotechnology, food allergies and safety assessment, and consumer benefits with regard to genetically modified food. Tomorrow's foods will be obtained from genetically modified crops, offering consumers higher nutritional value and more of it. Our medications will be obtained through a variety of biotechnological procedures yielding more potent and specific medications for diseases and vaccines. In order to make this view of the future come to light, John A. Thomas and Roy L. Fuchs have updated their classic in order to keep readers one step ahead. Written by internationally recognized molecular biologists, plant agronomists, microbiologists, toxicologists, nutritionists, and regulatory authorities, this third edition is an excellent and authoritative resource, making it a valuable resource to any biomedical library or scientific bookshelf. Provides timely coverage on topics of agribiotechnology and biotherapeutics Describes the recent progress in genetically modified crops and their safety Presents an update of the newer developments in therapeutic agents Discusses role of genetically modified microorganisms in the development of new food products Outlines various global regulatory issues relating to GM crops Addresses environmental and ecological topics related to GM crops

Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Author : Danuta J. Herzyk
Publisher : John Wiley & Sons
ISBN 13 : 0470386371
Total Pages : 433 pages
Book Rating : 4.4/5 (73 download)

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Book Synopsis Immunotoxicology Strategies for Pharmaceutical Safety Assessment by : Danuta J. Herzyk

Download or read book Immunotoxicology Strategies for Pharmaceutical Safety Assessment written by Danuta J. Herzyk and published by John Wiley & Sons. This book was released on 2008-11-21 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates Helps readers understand the significance of the methods and approaches to immunotoxicology testing Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing