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.

Biotechnology and Safety Assessment

Author : John A. Thomas
Publisher : Elsevier
ISBN 13 : 008052818X
Total Pages : 505 pages
Book Rating : 4.0/5 (85 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 505 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

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 : 0470745916
Total Pages : 492 pages
Book Rating : 4.4/5 (77 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 2013-04-29 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.

Accelerating the Development of Biomarkers for Drug Safety

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309142318
Total Pages : 101 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Accelerating the Development of Biomarkers for Drug Safety by : Institute of Medicine

Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2009-07-20 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 477 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 477 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.

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

Preparing for Future Products of Biotechnology

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309452058
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

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.

Global Approach in Safety Testing

Author : Jan Willem van der Laan
Publisher : Springer Science & Business Media
ISBN 13 : 1461459508
Total Pages : 322 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Global Approach in Safety Testing by : Jan Willem van der Laan

Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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”.

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

Food Safety of Proteins in Agricultural Biotechnology

Author : Bruce G. Hammond
Publisher : CRC Press
ISBN 13 : 1420005731
Total Pages : 318 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Food Safety of Proteins in Agricultural Biotechnology by : Bruce G. Hammond

Download or read book Food Safety of Proteins in Agricultural Biotechnology written by Bruce G. Hammond and published by CRC Press. This book was released on 2007-11-28 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from internationally recognized experts, Food Safety of Proteins in Agricultural Biotechnology comprehensively addresses how toxicology testing of proteins should be accomplished and how protein safety assessments should be carried out. Beginning with a background on protein biology, the book delineates the fundamental difference

Haschek and Rousseaux's Handbook of Toxicologic Pathology

Author : Wanda M. Haschek
Publisher : Elsevier
ISBN 13 : 0080491448
Total Pages : 2160 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Haschek and Rousseaux's Handbook of Toxicologic Pathology by : Wanda M. Haschek

Download or read book Haschek and Rousseaux's Handbook of Toxicologic Pathology written by Wanda M. Haschek and published by Elsevier. This book was released on 2001-10-16 with total page 2160 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive understanding of toxicologic pathology is essential for those in industry, academia, and government who make decisions concerning the safety and efficacy of drugs and chemicals. Toxicologic pathology relies heavily on the fields of both toxicology and pathology, which are well covered individually in various texts and references; however, there are few texts that address the field of toxicologic pathology. The Handbook of Toxicologic Pathology fills this void and is thus essential for all health professionals within or interacting with the field of toxicologic pathology. This two-volume set provides the reader with a single reference for toxicologic pathology. In volume I, the book covers toxicologic pathology in its basic aspects, including its definition, the basic biochemical and morphologic mechanisms underlying the discipline, the basic practice of toxicologic pathology (including special techniques) and issues essential to the understanding of toxicologic pathology such as risk assessment, experimental design, and statistical analysis. Next, the book moves to specific issues affecting the "practice" toxicologic pathology, including issues such as knowledge management, regulatory affairs and writing pathology reports. Finally, Volume I closes with several chapters that deal with specific classes of environmental toxicants such as endocrine disruptors and heavy metals. Volume II addresses the toxicologic pathology in a thoroughly standardized systems manner, addressing the basic structure and function of a particular organ system, its response to toxic injury, mechanisms of injury and methods of evaluation of such injury. Key Features * Easy to find, up-to-date reference information * Graphic and photographic plates * Current hot topics and anticipated changes in toxicologic pathology * Standardized chapter format * Topics that are addressed in both a broad and deep manner, resulting in a stand alone text * Added coverage of important environmental toxicants * Chapters authored by internationally recognized experts and peer-reviewed

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

Information Resources in Toxicology

Author : Philip Wexler
Publisher : Academic Press
ISBN 13 : 0127447709
Total Pages : 953 pages
Book Rating : 4.1/5 (274 download)

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Book Synopsis Information Resources in Toxicology by : Philip Wexler

Download or read book Information Resources in Toxicology written by Philip Wexler and published by Academic Press. This book was released on 2000 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: History: -- K.D. Watson, P. Wexler, and J. Everitt. -- Highlights in the History of Toxicology. -- Selected References in the History of Toxicology. -- A Historical Perspective of Toxicology Information Systems. -- Books and Special Documents: -- G.L. Kennedy, Jr., P. Wexler, N.S. Selzer, and L.A. Malley. -- General Texts. -- Analytical Toxicology. -- Animals in Research. -- Biomonitoring/Biomarkers. -- Biotechnology. -- Biotoxins. -- Cancer. -- Chemical Compendia. -- Chemical--Cosmetics and Other Consumer. -- Products. -- Chemical--Drugs. -- Chemical--Dust and Fibers. -- Chemical--Metals. -- Chemicals--Pesticides -- Chemicals--Solvents. -- Chemical--Selected Chemicals. -- Clinical Toxicology. -- Developmental and Reproductive Toxicology. -- Environmental Toxicology--General. -- Environmental Toxicology-- Aquatic. -- Environmental Toxicology--Atmospheric. -- Environmental Toxicology--Hazardous Waste. -- Environmental Toxicology--Terrestrial. -- Environmental Toxicology--Wildlife. -- Ep ...

Biomedical Product and Materials Evaluation

Author : P.V. Mohanan
Publisher : Woodhead Publishing
ISBN 13 : 012824173X
Total Pages : 808 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Biomedical Product and Materials Evaluation by : P.V. Mohanan

Download or read book Biomedical Product and Materials Evaluation written by P.V. Mohanan and published by Woodhead Publishing. This book was released on 2022-01-22 with total page 808 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. - Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more - Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies - Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Pharmaceutical Toxicology in Practice

Author : Alberto Lodola
Publisher : John Wiley & Sons
ISBN 13 : 0470922729
Total Pages : 280 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Pharmaceutical Toxicology in Practice by : Alberto Lodola

Download or read book Pharmaceutical Toxicology in Practice written by Alberto Lodola and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.