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The Application Of Mechanistic Modelling As A Tool In Drug Disposition And Risk Assessment
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Book Synopsis Handbook of Drug Metabolism, Third Edition by : Paul G. Pearson
Download or read book Handbook of Drug Metabolism, Third Edition written by Paul G. Pearson and published by CRC Press. This book was released on 2019-05-20 with total page 755 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.
Book Synopsis In Vitro-In Vivo Correlations by : David B. Young
Download or read book In Vitro-In Vivo Correlations written by David B. Young and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
Book Synopsis Molecular and Cellular Toxicology by : Lesley Stanley
Download or read book Molecular and Cellular Toxicology written by Lesley Stanley and published by John Wiley & Sons. This book was released on 2014-06-03 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicology is the study of the adverse effects of chemical, physical, or biological agents on people, animals, and the environment. Toxicologists are trained to investigate, interpret, and communicate the nature of those effects. Over the last ten years the subject of toxicology has changed dramatically, moving from a discipline which was once firmly wedded to traditional methods to one which is keen to embrace the innovative techniques emerging from the developing fields of cell culture and molecular biology. There is an acute need for this to be reflected in a paradigm shift which takes advantage of the opportunities offered by modern developments in the life sciences, including new in vitro and in silico approaches, alternative whole organism (non-mammalian) models and the exploitation of ‘omics methods, high throughput screening (HTS) techniques and molecular imaging technologies. This concise, accessible introduction to the field includes the very latest concepts and methodologies. It provides MSc, PhD and final year undergraduate students in pharmacy, biomedical and life sciences, as well as individuals starting out in the cosmetics, consumer products, pharmaceutical and testing industries, with everything they need to know to get to grips with the fast moving field of toxicology and the current approaches used in the risk assessment of drugs and chemicals.
Book Synopsis The History of Alternative Test Methods in Toxicology by :
Download or read book The History of Alternative Test Methods in Toxicology written by and published by Academic Press. This book was released on 2018-10-20 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.
Book Synopsis Physiologically Based Pharmacokinetic (PBPK) Modeling by : Jeffrey W. Fisher
Download or read book Physiologically Based Pharmacokinetic (PBPK) Modeling written by Jeffrey W. Fisher and published by Academic Press. This book was released on 2020-05-20 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physiologically Based Pharmacokinetic (PBPK) Modeling: Methods and Applications in Toxicology and Risk Assessment presents foundational principles, advanced techniques and applications of PBPK modeling. Contributions from experts in PBPK modeling cover topics such as pharmacokinetic principles, classical physiological models, the application of physiological models for dose-response and risk assessment, the use of in vitro information, and in silico methods. With end-of-chapter exercises that allow readers to practice and learn the skills associated with PBPK modeling, dose-response, and its applications to safety and risk assessments, this book is a foundational resource that provides practical coverage of PBPK modeling for graduate students, academics, researchers, and more. - Provides end-of-chapter exercises to teach hands-on computational tools used in toxicology - Supplies computer code and explanations and includes examples of applied models used in regulatory toxicology and research - Authored by expert editors and contributors who are among the best PBPK modelers in the world
Book Synopsis Overcoming Obstacles in Drug Discovery and Development by : Kan He
Download or read book Overcoming Obstacles in Drug Discovery and Development written by Kan He and published by Elsevier. This book was released on 2023-05-18 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development. - Provides real-world case studies in drug discovery and the development of drugs - Illustrates the use of critical thinking and problem solving in approaching preclinical and clinical problems in drug discovery and development - Illustrates and analyses examples of successes and failures in drug discovery and development that have not previously been reported
Book Synopsis Artificial Intelligence, Machine Learning, and Deep Learning in Precision Medicine in Liver Diseases by : Tung-Hung Su
Download or read book Artificial Intelligence, Machine Learning, and Deep Learning in Precision Medicine in Liver Diseases written by Tung-Hung Su and published by Elsevier. This book was released on 2023-08-20 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Artificial Intelligence, Machine Learning, and Deep Learning in Precision Medicine and Liver Diseases: Concept, Technology, Application, and Perspectives combines four major applications of artificial intelligence (AI) within the field of clinical medicine specific to liver diseases: radiology imaging, electronic health records, pathology, and multiomics. The book provides a state-of-the-art summary of AI in precision medicine in hepatology, clarifying the concept and technology of AI and pointing to the current and future applications of AI within the field of hepatology. Coverage includes data preparation, methodology and application within disease-specific cases in fibrosis, viral and steatohepatitis, cirrhosis, hepatocellular carcinoma, acute liver failure, liver transplantation, and more. The ethical and legal issues of AI and future challenges and perspectives are also discussed. By highlighting many new AI applications which can further research, diagnosis, and treatment, this reference is the perfect resource for both practicing hepatologists and researchers focused on AI applications in medicine. - Introduces the concept of AI and machine learning of precision medicine in the field of hepatology - Discusses current challenges of AI in healthcare and proposes future tasks for AI in new workflows of healthcare - Provides real-world applications from domain experts in clinical medicine
Book Synopsis Predictive Toxicology in Drug Safety by : Jinghai J. Xu
Download or read book Predictive Toxicology in Drug Safety written by Jinghai J. Xu and published by Cambridge University Press. This book was released on 2010-09-27 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Physiologically Based Pharmacokinetic Modeling by : Micaela Reddy
Download or read book Physiologically Based Pharmacokinetic Modeling written by Micaela Reddy and published by John Wiley & Sons. This book was released on 2005-06-14 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: A definitive, single source of information on PBPK modeling Physiologically-based pharmacokinetic (PBPK) modeling is becomingincreasingly important in human health risk assessments and insupporting pharmacodynamic modeling for toxic responses. Organizedby classes of compounds and modeling purposes so users can quicklyaccess information, this is the first comprehensive reference ofits kind. This book presents an overview of the underlying principles of PBPKmodel development. Then it provides a compendium of PBPK modelinginformation, including historical development, specific modelingchallenges, and current practices for: * Halogenated Alkanes * Halogenated Alkenes * Alkene and Aromatic Compounds * Reactive Vapors in the Nasal Cavity * Alkanes, Oxyhydrocarbons, and Related Compounds * Pesticides and Persistent Organic Pollutants * Dioxin and Related Compounds * Metals and Inorganic Compounds * Drugs * Antineoplastic Agents * Perinatal Transfer * Mixtures * Dermal Exposure Models In addition to pinpointing specific information, readers canexplore diverse modeling techniques and applications. Anauthoritative reference for toxicologists, ecotoxicologists, riskassessors, regulators, pharmacologists, pharmacists, and graduatestudents in pharmacokinetics and toxicology, Physiologically-BasedPharmacokinetic Modeling compiles information from leaders in thefield and discusses future directions for PBPK modeling.
Book Synopsis The Art and Science of Physiologically-Based Pharmacokinetics Modeling by : Rodrigo Cristofoletti
Download or read book The Art and Science of Physiologically-Based Pharmacokinetics Modeling written by Rodrigo Cristofoletti and published by CRC Press. This book was released on 2024-07-15 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This state-of-the-art text describes the science behind the system and drug-dependent components of PBPK models, its applications in translational and regulatory science, e.g., guiding drug discovery and development, and supporting precision medicine initiatives. To incorporate state-of-the-art knowledge, each chapter is written by leaders in the field and illustrated by clear case studies. Connecting basic and applied science, this book explores the potential of PBPK modeling for improving therapeutics and is designed for a wide audience encompassing graduate students as well as biopharmaceutics scientists and clinical pharmacologists. Features: 1. Provides a basic understanding of the physiologically-based pharmacokinetic modeling and its applications 2. Assists the reader in understanding product performance to allow for rapid product development and establish bioequivalence 3. Well-constructed content and added value of real examples 4. Illustrates how using available resources via modeling and simulation leads to a reduction in the costs related to drug development, which directly affects the costs to patients
Book Synopsis Translating Molecules into Medicines by : Shobha N. Bhattachar
Download or read book Translating Molecules into Medicines written by Shobha N. Bhattachar and published by Springer. This book was released on 2017-04-21 with total page 471 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field. The authors of each chapter address the paradox between the molecular understanding of diseases, drug discovery, and drug development. Laying out the detailed trends from various fields, different chapters are dedicated to target engagement, toxicological safety assessments, and the compelling relationship of optimizing early clinical studies with design strategies. The book also highlights the importance of balancing the three pillars: sufficient efficacy, acceptable safety and appropriate pharmacokinetics, all of which are crucial to successful efforts in discovery and development. With discussions regarding the combined approaches of molecular research, personalized medicine, pre-clinical and clinical development, as well as targeted therapies—this compendium is a flexible fit, perfect for professionals in the pharmaceutical industry and related academic fields.
Book Synopsis Hayes' Principles and Methods of Toxicology, Sixth Edition by : A. Wallace Hayes
Download or read book Hayes' Principles and Methods of Toxicology, Sixth Edition written by A. Wallace Hayes and published by CRC Press. This book was released on 2014-10-10 with total page 2186 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hayes’ Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chapters that address the advances and developments since the fifth edition, the book presents everything toxicologists and students need to know to understand hazards and mechanisms of toxicity, enabling them to better assess risk. The book begins with the four basic principles of toxicology—dose matters, people differ, everything transforms, and timing is crucial. The contributors discuss various agents of toxicity, including foodborne, solvents, crop protection chemicals, radiation, and plant and animal toxins. They examine various methods for defining and measuring toxicity in a host of areas, including genetics, carcinogenicity, toxicity in major body systems, and the environment. This new edition contains an expanded glossary reflecting significant changes in the field. New topics in this edition include: The importance of dose–response Systems toxicology Food safety The humane use and care of animals Neurotoxicology The comprehensive coverage and clear writing style make this volume an invaluable text for students and a one-stop reference for professionals.
Book Synopsis Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters by : Shuguang Ma
Download or read book Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters written by Shuguang Ma and published by Elsevier. This book was released on 2020-07-09 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade's numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. - Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues - Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included - Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics - All chapters are written by experts with a wide range of practical experience from the industry and academia
Book Synopsis ADME-Enabling Technologies in Drug Design and Development by : Donglu Zhang
Download or read book ADME-Enabling Technologies in Drug Design and Development written by Donglu Zhang and published by John Wiley & Sons. This book was released on 2012-04-13 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the development of analytical techniques such as mass spectrometry and molecular biology 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 Development focuses on the current state of the art in the field, presenting a comprehensive review of the latest tools for generating ADME data in drug discovery. It examines the broadest possible range of available technologies, giving readers the information they need to choose the right tool for a given application, a key requisite for obtaining favorable results in a timely fashion for regulatory filings. With over thirty contributed chapters by an international team of experts, the book provides: A thorough examination of current tools, covering both electronic/mechanical technologies and biologically based ones Coverage of applications for each technology, including key parameters, optimal conditions for intended results, protocols, and case studies Detailed discussion of emerging tools and techniques, from stem cells and genetically modified animal models to imaging technologies Numerous figures and diagrams throughout the text Scientists and researchers in drug metabolism, pharmacology, medicinal chemistry, pharmaceutics, toxicology, and bioanalytical science will find ADME-Enabling Technologies in Drug Design and Development an invaluable guide to the entire drug development process, from discovery to regulatory issues.
Book Synopsis ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins by : Honghui Zhou
Download or read book ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2015-10-26 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain
Download or read book Cumulated Index Medicus written by and published by . This book was released on 1987 with total page 1246 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Handbook of Functionalized Nanomaterials by : Vineet Kumar
Download or read book Handbook of Functionalized Nanomaterials written by Vineet Kumar and published by Elsevier. This book was released on 2021-08-23 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Functionalized Nanomaterials: Environmental Health and Safety discusses the reactive properties of FNMs used in a range of applications, and their toxic impact on the environment. Nanomaterials have unique properties that can make them highly reactive. This reactivity can cause unwanted interactions with living cells, an increase in oxidative stress or damage to genetic material - resulting in damage to the environment and local wildlife. This negative impact is often further increased after surface functionalization of nanomaterials with other materials which offer unique properties of their own. To ensure environmental safety and ecological balance, rigorous toxicity testing of functionalized nanomaterials (FNMs) is necessary. This book discusses the toxicological uncertainties of FNMs and the limitations of FNMs in a range of applications. Later chapters propose methods to reliably assess the harm that functionalized nanomaterials can cause to the environment and wildlife, as well covering recent developments in the field of environmental health safety. The book concludes with a discussion on the future prospects of safe functionalized nanomaterials. - Offers a novel, integrated approach, bridging the gap between FNMs and environmental health and safety - Analyses the reactive properties of FNMs and their toxicological potential - Provides an in-depth look at the impact of functionalized nanomaterials on the environment
