Advertisement
| preclinical development handbook toxicology: Preclinical Development Handbook Shayne Cox Gad, 2008-03-21 A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin. |
| preclinical development handbook toxicology: Preclinical Development Handbook Shayne Cox Gad, 2008-03-21 A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin. |
| preclinical development handbook toxicology: A Comprehensive Guide to Toxicology in Preclinical Drug Development Ali S. Faqi, 2012-10-18 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 |
| preclinical development handbook toxicology: Preclinical Drug Development, Second Edition Mark Rogge, David R. Taft, 2009-09-25 Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: Pharmacokinetics Modeling and simulation Formulation and routes of administration Toxicity evaluations The assessment of drug absorption and metabolism Interspecies scaling Lead molecule selection and optimization via profiling Screening using in silico and in vitro toxicity evaluations The book also includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences. |
| preclinical development handbook toxicology: Biomarkers in Drug Development Michael R. Bleavins, Claudio Carini, Mallé Jurima-Romet, Ramin Rahbari, 2011-09-20 Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development. |
| preclinical development handbook toxicology: Genomics in Drug Discovery and Development Dimitri Semizarov, Eric Blomme, 2008-11-03 Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists. |
| preclinical development handbook toxicology: Predictive Toxicology in Drug Safety Jinghai J. Xu, Laszlo Urban, 2010-09-27 According to the Institute of Medicine (IOM) and U.S. Food and Drug Administration (FDA), 'developing new scientific approaches to detecting, understanding, predicting and preventing adverse events' was a critical path to the future of drug safety. This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment and promotes evidence-based toxicology. Each specific area of toxicology relevant for drug discovery is discussed in detail, including theory, experimental approaches and data interpretation supported by comprehensive up-to-date references. Many chapters provide fascinating case studies, which are of general interest for those who have basic science training and are interested in how chemicals interact with the human body. |
| preclinical development handbook toxicology: Clinical Trials Handbook Shayne Cox Gad, 2009-07-07 Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development. |
| preclinical development handbook toxicology: Preclinical Development Handbook, 2-Volume Set Shayne Cox Gad, 2008-03-14 This book brings together in one resource an overview of the preclinical process along with a compendium of methods and techniques that need to be considered when developing a new drug. The book details steps in the preclinical process including: prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, toxicity, modeling, and regulations. It includes problems that are encountered, solutions to these problems, and limitations of various methods and techniques used in determining the safety and efficacy of a drug at this stage. |
| preclinical development handbook toxicology: Optimization in Drug Discovery Gary W. Caldwell, Zhengyin Yan, 2016-08-23 Thoroughly revised and updated, Optimization in Drug Discovery: In Vitro Methods, Second Edition presents a wide spectrum of in vitro assays including formulation, plasma binding, absorption and permeability, cytochrome P450 (CYP) and UDP-glucuronosyltransferases (UGT) metabolism, CYP inhibition and induction, drug transporters, drug-drug interactions via assessment of reactive metabolites, genotoxicity, and chemical and photo-mutagenicity assays. Written for the Methods in Pharmacology and Toxicology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Expert authors have developed and utilized these in vitro assays to achieve “drug-like” characteristics in addition to efficacy properties and good safety profiles of drug candidates. Comprehensive and up-to-date, Optimization in Drug Discovery: In Vitro Methods, Second Edition aims to guide researchers down the difficult path to successful drug discovery and development. |
| preclinical development handbook toxicology: Handbook of Pre-Clinical Continuous Intravenous Infusion Guy Healing, David Smith, 2000-08-31 Any scientist or technician involved in pre-clinical drug studies knows that infusing animal models with test substances is no simple matter, especially if one wants to do it humanely as well as guarantee results that are not compromised by the procedure. The challenge becomes compounded if one is employing a variety of species. What works for a rat or mouse does not necessarily work for a rabbit or primate. The Handbook of Pre-clinical Continuous Intravenous Infusion answers the needs of researchers and technicians by providing complete instructions for a wide range of infusion techniques delivered to several species. With sections devoted to rats, mice, rabbits, dogs, mini-pigs, and nonhuman primates (both large and small), this thorough text gives step-by-step instructions for the use of a variety of techniques, and equipment. It includes procedures for multidose infusion toxicity and reproductive toxicology studies, and provides guidance on the use of a variety of equipment, including tail cuffs, harnesses, and implanted buttons. It also offers detailed information on surgical preparation for primates and mini-pigs, along with advice about the use of preoperative anesthesia, post surgical analgesics, and antibiotic administration, as well as valuable input on surgical suite design. ... I was amazed and gratified about the level of detail and the practical emphasis on technical expertise and animal well-being. This book is unique in having that as an overt aim. From the Foreword, David B. Morton, University of Birmingham, UK The text concludes with a chapter on general non-species-specific information that discusses common pathological findings in continuous infusion studies, the use of mini-osmatic pumps, and controllable variables such as vehicles, rates of administration and volumes. With contributions from several established experts in the handling of pre-clinical animal models, this authoritative volume removes the need for any guesswork, allowing technicians and researchers to proceed with confidence in undertaking critical studies. |
| preclinical development handbook toxicology: Peptide Drug Discovery and Development Miguel Castanho, Nuno Santos, 2011-10-24 Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the bench to bedside translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed. |
| preclinical development handbook toxicology: Innovative Dosage Forms Yogeshwar Bachhav, 2019-12-04 Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists. |
| preclinical development handbook toxicology: Drug Delivery Aspects Ranjita Shegokar, 2020-03-30 Drug Delivery Aspects reviews additional features of drug delivery systems, along with the standard formulation development, like preclinical testing, conversion into solid dosage forms, roles of excipients and polymers used on stability and sterile processing. There is a focus on formulation engineering and related large scale (GMP) manufacturing, regulatory, and functional aspects of drug delivery systems. A detailed discussion on biologics and vaccines gives insights to readers on new developments in this direction. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems. |
| preclinical development handbook toxicology: Good Research Practice in Non-Clinical Pharmacology and Biomedicine Anton Bespalov, Martin C. Michel, Thomas Steckler, 2020-02-20 This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine. |
| preclinical development handbook toxicology: Early Drug Development Mitchell N. Cayen, 2010-08-09 The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies. |
| preclinical development handbook toxicology: Developmental and Reproductive Toxicology Ronald D. Hood, Ronald D Hood, 2005-08-30 Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers e |
| preclinical development handbook toxicology: Prodrugs and Targeted Delivery Jarkko Rautio, 2011-01-11 This topical reference and handbook addresses the chemistry, pharmacology, toxicology and the patentability of prodrugs, perfectly mirroring the integrated approach prevalent in today's drug design. It summarizes current experiences and strategies for the rational design of prodrugs, beginning at the early stages of the development process, as well as discussing organ- and site-selective prodrugs. Every company employing medicinal chemists will be interested in this practice-oriented overview of a key strategy in modern drug discovery and development. |
| preclinical development handbook toxicology: Drug Discovery and Evaluation: Methods in Clinical Pharmacology H.Gerhard Vogel, Jochen Maas, Alexander Gebauer, 2010-12-15 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. |
| preclinical development handbook toxicology: Case Studies in Modern Drug Discovery and Development Xianhai Huang, Robert G. Aslanian, 2012-05-29 Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects. |
| preclinical development handbook toxicology: Drug Transporters Glynis Nicholls, Kuresh Youdim, 2016-08-16 Understanding and quantifying the effects of membrane transporters within the human body is essential for modulating drug safety and drug efficacy. In this first volume on Drug Transporters, the current knowledge and techniques in the transporter sciences and their relations to drug metabolism and pharmacokinetics are comprehensively reviewed. The second volume of the book is specifically dedicated to emerging science and technologies, highlighting potential areas for future advances within the drug transporter field. The topics covered in both volumes ensure that all relevant aspects of transporters are described across the drug development process, from in silico models and preclinical tools through to the potential impact of transporters in the clinic. Contributions are included from expert leaders in the field, at-the-bench industrial scientists, renowned academics and international regulators. Case studies and emerging developments are highlighted, together with the merits and limitations of the available methods and tools, and extensive references to reviews on specific in-depth topics are also included for those wishing to pursue their knowledge further. As such, this text serves as an essential handbook of information for postgraduate students, academics, industrial scientists and regulators who wish to understand the role of transporters in absorption, distribution, metabolism, and excretion processes. In addition, it is also a useful reference tool on the models and calculations necessary to predict their effect on human pharmacokinetics and pharmacodynamics. |
| preclinical development handbook toxicology: Handbook of Stability Testing in Pharmaceutical Development Kim Huynh-Ba, 2008-11-16 This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices. |
| preclinical development handbook toxicology: A Comprehensive Guide to Toxicology in Nonclinical Drug Development Ali S. Faqi, 2016-11-03 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 |
| preclinical development handbook toxicology: Drug Discovery and Evaluation Hans G. Vogel, Wolfgang H. Vogel, 2013-04-17 This reference book contains a comprehensive selection of the most frequently used assays for reliably detecting pharmacological effects of potential drugs, including tests for cardiovascular, analgesic, psychotropic, metabolic, endocrine, respiratory, renal, and immunomodulatory activities. Each of the over 700 assays comprises a detailed protocol with the purpose and rationale of the method, a description of the experimental procedure, a critical assessment of the results and their pharmacological and clinical relevance, and pertinent references. Identification of specific tests is facilitated by the enclosed CD-ROM which allows for a quick and full text research. An appendix with guidelines and legal regulations for animal experiments in various countries will help to plan these experiments properly in accordance with the welfare of laboratory animals. |
| preclinical development handbook toxicology: Fundamentals of Toxicologic Pathology Wanda M. Haschek, Colin George Rousseaux, Matthew A. Wallig, 2009 Unlike most books on the subject, Fundamentals of Toxicologic Pathology second edition offers fundamentally comprehensive coverage of veterinary pathology as it relates to comparative toxicologic pathology. This reference is a condensation of basic toxicologic-pathology concepts and organ-system responses from the Handbook of Toxicologic Pathology with updated information and expansion of diagnostic pathology as it relates to toxic injury. It offers concise and valuable information regarding organ-system toxicologic pathology for graduate students of toxicologic pathology and scientists working in academia or industry. |
| preclinical development handbook toxicology: Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems Ashok Katdare, Mahesh Chaubal, 2006-07-28 To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics. |
| preclinical development handbook toxicology: Anticancer Drug Development Bruce C. Baguley, David J. Kerr, 2001-11-17 Here in a single source is a complete spectrum of ideas on the development of new anticancer drugs. Containing concise reviews of multidisciplinary fields of research, this book offers a wealth of ideas on current and future molecular targets for drug design, including signal transduction, the cell division cycle, and programmed cell death. Detailed descriptions of sources for new drugs and methods for testing and clinical trial design are also provided. - One work that can be consulted for all aspects of anticancer drug development - Concise reviews of research fields, combined with practical scientific detail, written by internationally respected experts - A wealth of ideas on current and future molecular targets for drug design, including signal transduction, the cell division cycle, and programmed cell death - Detailed descriptions of the sources of new anticancer drugs, including combinatorial chemistry, phage display, and natural products - Discussion of how new drugs can be tested in preclinical systems, including the latest technology of robotic assay systems, cell culture, and experimental animal techniques - Hundreds of references that allow the reader to access relevant scientific and medical literature - Clear illustrations, some in color, that provide both understanding of the field and material for teaching |
| preclinical development handbook toxicology: A Comprehensive Guide to Toxicology in Preclinical Drug Development Ali S. Faqi, 2012-11-02 A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics -- |
| preclinical development handbook toxicology: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| preclinical development handbook toxicology: Dose Finding in Drug Development Naitee Ting, 2006-03-07 If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined. |
| preclinical development handbook toxicology: A Handbook of Bioanalysis and Drug Metabolism Gary Evans, 2021-10-15 Recent years have seen a greater industrial emphasis in undergraduate and postgraduate courses in the pharmaceutical and chemical sciences. However, textbooks have been slow to adapt, leaving the field without a text/reference that is both instructional and practical in the industrial setting – until now. A Handbook of Bioanalysis and Drug Metabolismis a stimulating new text that examines the techniques, methodology, and theory of bioanalysis, pharmacokinetics, and metabolism from the perspective of scientists with extensive professional experience in drug discovery and development. These three areas of research help drug developers to optimize the active component within potential drugs thereby increasing their effectiveness, and to provide safety and efficacy information required by regulators when granting a drug license. Professionals with extensive experience in drug discovery and development as well as specialized knowledge of the individual topics contributed to each chapter to create a current and well-credentialed text. It covers topics such as high performance liquid chromatography, protein binding, pharmacokinetics and drug–drug interactions. The unique industrial perspective helps to reinforce theory and develop valuable analytical and interpreting skills. This text is an invaluable guide to students in courses such as pharmaceutical science, pharmacology, chemistry, physiology and toxicology, as well as professionals in the biotechnology industry. |
| preclinical development handbook toxicology: Integrated Strategies for Drug Discovery Using Mass Spectrometry Mike S. Lee, 2005-09-02 New strategies and techniques for today's fast-paced discoveryprocess Today, the pressure is on for high-throughput approaches toaccelerate the generation, identification, and optimization ofmolecules with desirable drug properties. As traditional methods ofanalysis become antiquated, new analytical strategies andtechniques are necessary to meet sample throughput requirements andmanpower constraints. Among them, mass spectrometry has grown to bea front-line tool throughout drug discovery. Integrated Strategies for Drug Discovery Using Mass Spectrometryprovides a thorough review of current analytical approaches,industry practices, and strategies in drug discovery. The topicsrepresent current industry benchmarks in specific drug discoveryactivities that deal with proteomics, biomarker discovery,metabonomic approaches for toxicity screening, lead identification,compound libraries, quantitative bioanalytical support,biotransformation, reactive metabolite characterization, leadoptimization, pharmaceutical property profiling, sample preparationstrategies, and automation. THIS BOOK: * Clearly explains how drug discovery and mass spectrometry areinterconnected * Discusses the uses and limitations of various types of massspectrometry in various aspects of drug discovery * Prominently features analytical applications that requiretrace-mixture analysis * Provides industry applications and real-world examples * Shares historical background information on various techniques toaid in the understanding of how and why new methods are now beingemployed to analyze samples |
| preclinical development handbook toxicology: The Oxford Handbook of Identity Development Kate C. McLean, Moin U. Syed, 2015 Identity is defined in many different ways in various disciplines in the social sciences and sub-disciplines within psychology. The developmental psychological approach to identity is characterized by a focus on developing a sense of the self that is temporally continuous and unified across the different life spaces that individuals inhabit. Erikson proposed that the task of adolescence and young adulthood was to define the self by answering the question: Who Am I? There have been many advances in theory and research on identity development since Erikson's writing over fifty years ago, and the time has come to consolidate our knowledge and set an agenda for future research.The Oxford Handbook of Identity Development represents a turning point in the field of identity development research. Various, and disparate, groups of researchers are brought together to debate, extend, and apply Erikson's theory to contemporary problems and empirical issues. The result is a comprehensive and state-of-the-art examination of identity development that pushes the field in provocative new directions. Scholars of identity development, adolescent and adult development, and related fields, as well as graduate students, advanced undergraduates, and practitioners will find this to be an innovative, unique, and exciting look at identity development. |
| preclinical development handbook toxicology: Essentials of Toxicology for Health Protection David Baker, Lakshman Karalliedde, Virginia Murray, Robert Maynard, Norman HT Parkinson, 2012-03-15 Essentials of Toxicology for Health Protection is ideal as both a course book for students and a handbook for field professionals involved in responding to chemical incidents and local environmental concerns. Produced by Health Protection England, it offers a comprehensive and structured approach to dealing with toxicological problems worldwide. The text covers both the basics of toxicology and its application to issues of topical concern such as contaminated land, food additives, and water and air pollution. Each chapter is written by an expert in the field, making Essentials of Toxicology for Health Protection essential reading for all professionals in environmental public health, including: health protection consultants, specialists and trainees; public health practitioners; environmental health practitioners; environmental scientists; and staff of the emergency services, the water and waste industries, and other industrial and regulatory bodies. |
| preclinical development handbook toxicology: Drugs Rick Ng, 2008-10-22 Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. —Doody's Reviews, May 2009 The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials. —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected mini case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses. |
| preclinical development handbook toxicology: Pharmaceutical Suspensions Alok K. Kulshreshtha, Onkar N. Singh, G. Michael Wall, 2014-11-28 The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle. |
| preclinical development handbook toxicology: A Toxicologist's Guide to Clinical Pathology in Animals John E. Whalan, 2015-04-09 This guide provides an easy-to-use desk reference for diagnostic information on commonly used hematology, clinical chemistry and urinalysis parameters. Additional reference materials are provided as an aid in evaluating clinical pathology data. For many toxicologists, the evaluation of hematology, clinical chemistry and urinalysis data can be the most challenging aspect of animal toxicity studies. In a typical toxicity study, dozens of parameters are measured several times over the course of the study. There may be hundreds of data points, each of which needs to be considered. A Toxicologist’s Guide to Clinical Pathology in Animals will serve as an essential primer for toxicologists in training and in industry as well as for researchers and professionals in a veterinary practice or a laboratory. |
| preclinical development handbook toxicology: Genotoxic Impurities Andrew Teasdale, 2011-03-01 This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities. |
| preclinical development handbook toxicology: New Approaches to Drug Discovery Ulrich Nielsch, Ulrike Fuhrmann, Stefan Jaroch, 2016-04-08 This volume gives an overview of state of the art technologies and future developments in the field of preclinical pharmaceutical research. A balanced mix of experts from academia and industry give insight in selected new developments in the drug discovery pathway. The topics cover the different parts of the drug discovery process, starting with new developments in the target identification and validation area. The lead generation part as a next step focuses on the requirements and technologies to identify new small molecules as lead compounds for further optimization; in a second section the technologies to identify biologics as leads are addressed. The final part focuses on the pharmacological models and technologies to characterize new compounds and the impact of biomarkers to facilitate the transfer of drug candidates into the development phase. |
| preclinical development handbook toxicology: The Textbook of Pharmaceutical Medicine John P. Griffin, John O'Grady, 2006-02-07 New edition of succesful standard reference book for the pharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebook for the Diploma in Pharmaceutical Medicine, and is used as a standard reference throughout the pharmaceutical industry. The new edition includes greater coverage of good clinical practice, a completely revised statistics chapter, and more on safety. Covers the course information for the Diploma in Pharmaceutical Medicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe and regulation of therapeutic products in Australia |
Preclinical development - Wikipedia
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during …
Step 2: Preclinical Research - FDA
Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. The two types of preclinical research are: FDA requires...
The phases of preclinical and clinical trials - Profil
Deciding whether a drug is ready for clinical trials (the so-called move from bench to bedside) involves extensive preclinical studies that yield preliminary efficacy, toxicity, pharmacokinetic …
Preclinical Studies in Drug Development | Process, Importance
Feb 14, 2025 · This guide explores the importance, process, methods, and challenges of preclinical studies in drug development, providing an in-depth look into how new drugs are …
General Principles of Preclinical Study Design - PMC
In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of …
Preclinical Studies in Drug Development | PPD
Preclinical studies play a crucial role in the journey toward new drug discovery and development, assessing the safety, efficacy and potential side effects of a target compound or medical …
Overview of preclinical research - ScienceDirect
Jan 1, 2023 · Preclinical research is an essential starting point for the development and evaluation of nearly all translational, clinically relevant medical interventions. Understanding the …
Preclinical research - Latest research and news - Nature
May 23, 2025 · Preclinical research involves the evaluation of potential therapeutic interventions in cells and animals. Candidates for entry into clinical trials can then be selected based on their...
Preclinical | NIH
Preliminary testing of an investigational drug (or other intervention) in laboratory (in a test tube, for example) and animal studies. Preclinical studies take place before any testing in humans is …
Preclinical and Nonclinical Studies—What Is the Difference, and …
Jul 29, 2020 · Preclinical refers to studies occurring prior to clinical testing, while nonclinical refers to studies not related to, involving, or concerned with the direct observation and treatment of …
Preclinical development - Wikipedia
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and …
Step 2: Preclinical Research - FDA
Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. The two types of preclinical research are: FDA …
The phases of preclinical and clinical trials - Profil
Deciding whether a drug is ready for clinical trials (the so-called move from bench to bedside) involves extensive preclinical studies that yield preliminary efficacy, toxicity, …
Preclinical Studies in Drug Development | Process, Importanc…
Feb 14, 2025 · This guide explores the importance, process, methods, and challenges of preclinical studies in drug development, providing an in-depth look into how new …
General Principles of Preclinical Study Design - PMC
In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide …
