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A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
A Book

by Ali S. Faqi

  • Publisher : Academic Press
  • Release : 2012-11-16
  • Pages : 885
  • ISBN : 0123878152
  • Language : En, Es, Fr & De
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A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
A Book

by Ali S. Faqi

  • Publisher : Academic Press
  • Release : 2016-11-03
  • Pages : 986
  • ISBN : 0128036214
  • Language : En, Es, Fr & De
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A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Preclinical Development Handbook

Preclinical Development Handbook
Toxicology

by Shayne Cox Gad

  • Publisher : John Wiley & Sons
  • Release : 2008-03-21
  • Pages : 1080
  • ISBN : 9780470249048
  • Language : En, Es, Fr & De
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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

Preclinical Development Handbook
ADME and Biopharmaceutical Properties

by Shayne Cox Gad

  • Publisher : John Wiley & Sons
  • Release : 2008-03-14
  • Pages : 1352
  • ISBN : 0470248475
  • Language : En, Es, Fr & De
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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.

Drug Discovery Toxicology

Drug Discovery Toxicology
From Target Assessment to Translational Biomarkers

by Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy

  • Publisher : John Wiley & Sons
  • Release : 2016-04-18
  • Pages : 584
  • ISBN : 1119053331
  • Language : En, Es, Fr & De
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As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Flavonoid Pharmacokinetics

Flavonoid Pharmacokinetics
Methods of Analysis, Preclinical and Clinical Pharmacokinetics, Safety, and Toxicology

by Neal M. Davies,Jaime A. Yáñez

  • Publisher : John Wiley & Sons
  • Release : 2012-11-05
  • Pages : 352
  • ISBN : 1118354400
  • Language : En, Es, Fr & De
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SETS FORTH A FRAMEWORK FOR THE ANALYSIS AND STUDY OF FLAVONOIDS More and more dietary supplements contain flavonoids. These products are typically viewed as food rather than drug products by regulatory agencies and therefore not subjected to rigorous clinical trials before they are marketed to the general public. As a result, the use of flavonoid-containing supplements presents a potential public health risk. From discovery to therapeutic application, this book is a comprehensive guide to both achiral and chiral flavonoids, enabling researchers to perform essential preclinical and clinical pharmacokinetics studies in order to ensure the efficacy of flavonoids marketed for therapeutic use. Moreover, the book examines the safety and toxicology of flavonoids as well as flavonoid-drug interactions. With contributions from a multidisciplinary team of leading researchers, Flavonoids Pharmacokinetics reviews and synthesizes the most recent research findings and results from preclinical and clinical studies. The book begins with a comprehensive overview of polyphenols and flavonoids. Next, the book covers: Methods of analysis of achiral flavonoids Preclinical pharmacokinetic of flavonoids Toxicology and safety of flavonoids Methods of analysis for chiral flavonoids Clinical pharmacokinetics of flavonoids Flavonoids and drug interactions Throughout the book, the authors provide examples that demonstrate the use of pharmacokinetics concepts during the preclinical and clinical drug development process. Flavonoid Pharmacokinetics is written for pharmaceutical, food, and nutritional scientists and students, offering the tools they need to thoroughly analyze and test flavonoids and flavonoid-containing supplements to ensure their safety and efficacy.

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals
A Science-Based Approach to Facilitating Clinical Trials

by Joy A. Cavagnaro

  • Publisher : John Wiley & Sons
  • Release : 2013-03-07
  • Pages : 1064
  • ISBN : 1118679385
  • Language : En, Es, Fr & De
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"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: Includes an overview of biopharmaceuticals with information onregulation and methods of production Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.

Development and Approval of Combination Products

Development and Approval of Combination Products
A Regulatory Perspective

by Evan B. Siegel

  • Publisher : John Wiley & Sons
  • Release : 2008-06-09
  • Pages : 216
  • ISBN : 0470371196
  • Language : En, Es, Fr & De
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A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

ADME-Enabling Technologies in Drug Design and Development

ADME-Enabling Technologies in Drug Design and Development
A Book

by Donglu Zhang,Sekhar Surapaneni

  • Publisher : John Wiley & Sons
  • Release : 2012-04-13
  • Pages : 800
  • ISBN : 1118180763
  • Language : En, Es, Fr & De
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A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the developmentof analytical techniques such as mass spectrometry and molecularbiology tools, resulting in important advances in drug discovery,particularly in the area of absorption, distribution, metabolism,and excretion (ADME). ADME-Enabling Technologies in Drug Design and Developmentfocuses on the current state of the art in the field, presenting acomprehensive review of the latest tools for generating ADME datain drug discovery. It examines the broadest possible range ofavailable technologies, giving readers the information they need tochoose the right tool for a given application, a key requisite forobtaining favorable results in a timely fashion for regulatoryfilings. With over thirty contributed chapters by an internationalteam of experts, the book provides: A thorough examination of current tools, covering bothelectronic/mechanical technologies and biologically based ones Coverage of applications for each technology, including keyparameters, optimal conditions for intended results, protocols, andcase studies Detailed discussion of emerging tools and techniques, from stemcells and genetically modified animal models to imagingtechnologies Numerous figures and diagrams throughout the text Scientists and researchers in drug metabolism, pharmacology,medicinal chemistry, pharmaceutics, toxicology, and bioanalyticalscience will find ADME-Enabling Technologies in Drug Design andDevelopment an invaluable guide to the entire drug developmentprocess, from discovery to regulatory issues.

Global New Drug Development

Global New Drug Development
An Introduction

by Jan A. Rosier,Mark A. Martens,Josse R. Thomas

  • Publisher : John Wiley & Sons
  • Release : 2014-07-03
  • Pages : 424
  • ISBN : 1118414853
  • Language : En, Es, Fr & De
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The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely." —Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)

Botanical Drug Products

Botanical Drug Products
Recent Developments and Market Trends

by Jayant N. Lokhande,Yashwant V. Pathak

  • Publisher : CRC Press
  • Release : 2018-11-21
  • Pages : 274
  • ISBN : 1315352281
  • Language : En, Es, Fr & De
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Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process.

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
Chapter 6. Toxicogenomics – A Drug Development Perspective

by Yuping Wang,Jurgen Borlak,Weida Tong

  • Publisher : Elsevier Inc. Chapters
  • Release : 2013-07-16
  • Pages : 208
  • ISBN : 0128063556
  • Language : En, Es, Fr & De
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Although we have seen increased spending on drug research and development, the submission of new drug applications to the US Food and Drug Administration (FDA) has steadily decreased over the past 15 years. Meanwhile, toxicology is celebrating the ten-year anniversary of the introduction of toxicogenomics, a field that was anticipated to change our way of conducting toxicology with enhanced safety assessment. Despite the excitement, and a decade of further technical advancement, the anticipated benefits have been slow to reach the clinical bedside. The failure to translate toxicogenomics to drug development faster, illustrates the need for further innovations in its methodology as well as in its technology. This review introduces the concept of toxicogenomics, summarizes the prominent applications of this relatively young discipline in drug development, and provides a future perspective of advancement in this field.

Drug Discovery and Development, Third Edition

Drug Discovery and Development, Third Edition
A Book

by James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell

  • Publisher : CRC Press
  • Release : 2019-11-21
  • Pages : 668
  • ISBN : 1351625144
  • Language : En, Es, Fr & De
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Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development
Advancing Personalized Health Care

by Yihong Yao,Bahija Jallal,Koustubh Ranade

  • Publisher : Academic Press
  • Release : 2013-07-16
  • Pages : 208
  • ISBN : 0123977940
  • Language : En, Es, Fr & De
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Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters written by international authorities in industry and academia, this work is a truly unique presentation of the thoughts and approaches that lead to the development of personalized medicine. Intended for all those involved in clinical translational research, this book is the ideal resource for scientists searching for the applications, strategies and successful approaches of translational science in pharmaceutical development. Provides case studies in applications of pharmacodynamic and predictive markers in drug development in oncology, autoimmunity, respiratory diseases and infectious diseases Shows how to identify potential new therapeutic targets in different diseases and provides examples of potential new disease indications for life cycle management of drugs Authored by leading international experts from industry and academia

Oral Formulation Roadmap from Early Drug Discovery to Development

Oral Formulation Roadmap from Early Drug Discovery to Development
A Book

by Elizabeth Kwong

  • Publisher : John Wiley & Sons
  • Release : 2017-01-03
  • Pages : 272
  • ISBN : 1118907906
  • Language : En, Es, Fr & De
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Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

Innovative Dosage Forms

Innovative Dosage Forms
Design and Development at Early Stage

by Yogeshwar Bachhav

  • Publisher : John Wiley & Sons
  • Release : 2019-08-20
  • Pages : 352
  • ISBN : 3527812180
  • Language : En, Es, Fr & De
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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.

Drug Safety Evaluation

Drug Safety Evaluation
A Book

by Shayne Cox Gad

  • Publisher : John Wiley & Sons
  • Release : 2016-12-01
  • Pages : 918
  • ISBN : 111909741X
  • Language : En, Es, Fr & De
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This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Neurotoxins

Neurotoxins
A Book

by J. Eric McDuffie

  • Publisher : BoD – Books on Demand
  • Release : 2018-05-23
  • Pages : 156
  • ISBN : 178923168X
  • Language : En, Es, Fr & De
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Toxicologists seek to better understand the myriad of mechanisms responsible for neurotoxins. Because the incidence of neurobehavioral hazards and risks of exogenous compounds (e.g., natural toxins, synthetic molecules, and therapeutic agents) remain a subject matter of interest, predictive tools have evolved, including but not limited to novel translational in vitro models, biomarkers, newer epidemiological research tools, and well-accepted best practices for diagnosing neurotoxins in clinical practice. Taken together, the foreseen need to highlight some of the more appreciated and/or emerging tactical approaches in neurotoxicology results in a "one-stop reference" book, Neurotoxins.

Nonclinical Drug Administration

Nonclinical Drug Administration
Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

by Shayne C. Gad,Charles B. Spainhour

  • Publisher : CRC Press
  • Release : 2017-08-14
  • Pages : 420
  • ISBN : 1466502592
  • Language : En, Es, Fr & De
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If we will ever achieve Paul Ehrlich’s "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos," those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology. The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity. The book’s ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.

Stem Cells in Birth Defects Research and Developmental Toxicology

Stem Cells in Birth Defects Research and Developmental Toxicology
A Book

by Theodore P. Rasmussen

  • Publisher : John Wiley & Sons
  • Release : 2018-05-08
  • Pages : 368
  • ISBN : 1119283213
  • Language : En, Es, Fr & De
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This book contains material contributed by forward-looking scientists who work at the interface of stem cell research and applied science with the aim to improve human fetal safety and the understanding of human developmental and degenerative disorders. Provides important platforms and contemporary accounts of the state of stem cell research in the fields of toxicology and teratology Considers both in vitro uses of stem cells as platforms for teratology and also stem cellopathies, which are in vivo developmental and degenerative disorders Helps the pharmaceutical industry and safety and environmental authorities validate the status quo of in vitro toxicity test systems based on human pluripotent stem cells and their derivatives