Physiologically Based Pharmacokinetic Pbpk Modeling And Simulations

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Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations

Author : Sheila Annie Peters
Publisher : John Wiley & Sons
ISBN 13 : 1118140303
Total Pages : 399 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations by : Sheila Annie Peters

Download or read book Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations written by Sheila Annie Peters and published by John Wiley & Sons. This book was released on 2012-02-17 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only book dedicated to physiologically-based pharmacokinetic modeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has become increasingly widespread within the pharmaceutical industry over the last decade, but without one dedicated book that provides the information researchers need to learn these new techniques, its applications are severely limited. Describing the principles, methods, and applications of PBPK modeling as used in pharmaceutics, Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations fills this void. Connecting theory with practice, the book explores the incredible potential of PBPK modeling for improving drug discovery and development. Comprised of two parts, the book first provides a detailed and systematic treatment of the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics. The second part looks in greater detail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for a brief overview of the field as well as those who need more detail, the book includes a range of important learning aids. Featuring end-of-chapter keywords for easy reference a valuable asset for general or novice readers without a PBPK background along with an extensive bibliography for those looking for further information, Physiologically- Based Pharmacokinetic (PBPK) Modeling and Simulations is the essential single-volume text on one of the hottest topics in the pharmaceutical sciences today.

Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations

Author : Sheila Annie Peters
Publisher : John Wiley & Sons
ISBN 13 : 111949768X
Total Pages : 644 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations by : Sheila Annie Peters

Download or read book Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations written by Sheila Annie Peters and published by John Wiley & Sons. This book was released on 2021-10-12 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations The first book dedicated to the emerging field of physiologically based pharmacokinetic modeling (PBPK) Now in its second edition, Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulations: Principles, Methods, and Applications in the Pharma Industry remains the premier reference book throughout the rapidly growing PBPK user community. Using clear and concise language, author Sheila Annie Peters connects theory with practice as she explores the vast potential of PBPK modeling for improving drug discovery and development. This fully updated new edition covers key developments in the field of PBPK modelling and simulations that have emerged in recent years. A brand-new section provides case studies in different application areas of PBPK modelling, including drug-drug interaction, genetic polymorphism, renal impairment, and pediatric extrapolation. Additional chapters address topics such as model-informed drug development (MIDD) and expose readers to a wide range of current applications in the field. Throughout the book, substantially revised chapters simplify complex topics and offer a balanced view of both the opportunities and challenges of PBPK modelling. Providing timely and comprehensive coverage of one of the most exciting new areas of pharmaceutical science, this book: Describes the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics Features a wealth of new figures and case studies of the applications of PBPK modelling along the value chain in drug discovery and development Reflects the latest regulatory guidelines on the reporting of PBPK modelling analysis Includes access to a new companion website containing code, datasets, explanations of case examples in the text, and discussion of key developments in the field Contains a brief overview of the field, end-of-chapter keywords for easy reference, and an extensive bibliography Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry, Second Edition is an indispensable single-volume resource for beginning and intermediate practitioners across the pharmaceutical sciences in both industry and academia.

Physiologically Based Pharmacokinetic (PBPK) Modeling

Author : Jeffrey W. Fisher
Publisher : Academic Press
ISBN 13 : 0128196823
Total Pages : 348 pages
Book Rating : 4.1/5 (281 download)

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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

Human Biomonitoring for Environmental Chemicals

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309133904
Total Pages : 316 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Human Biomonitoring for Environmental Chemicals by : National Research Council

Download or read book Human Biomonitoring for Environmental Chemicals written by National Research Council and published by National Academies Press. This book was released on 2006-10-30 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomonitoring—a method for measuring amounts of toxic chemicals in human tissues—is a valuable tool for studying potentially harmful environmental chemicals. Biomonitoring data have been used to confirm exposures to chemicals and validate public health policies. For example, population biomonitoring data showing high blood lead concentrations resulted in the U.S. Environmental Protection Agency's (EPA's) regulatory reduction of lead in gasoline; biomonitoring data confirmed a resultant drop in blood lead concentrations. Despite recent advances, the science needed to understand the implications of the biomonitoring data for human health is still in its nascent stages. Use of the data also raises communication and ethical challenges. In response to a congressional request, EPA asked the National Research Council to address those challenges in an independent study. Human Biomonitoring for Environmental Chemicals provides a framework for improving the use of biomonitoring data including developing and using biomarkers (measures of exposure), research to improve the interpretation of data, ways to communicate findings to the public, and a review of ethical issues.

Drug Delivery Approaches

Author : Bret Berner
Publisher : John Wiley & Sons
ISBN 13 : 1119772753
Total Pages : 466 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Drug Delivery Approaches by : Bret Berner

Download or read book Drug Delivery Approaches written by Bret Berner and published by John Wiley & Sons. This book was released on 2021-08-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

Physiologically Based Pharmacokinetic Modeling

Author : Micaela Reddy
Publisher : John Wiley & Sons
ISBN 13 : 0471478776
Total Pages : 420 pages
Book Rating : 4.4/5 (714 download)

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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.

Transporters and Drug-Metabolizing Enzymes in Drug Toxicity

Author : Albert P. Li
Publisher : John Wiley & Sons
ISBN 13 : 1119170842
Total Pages : 530 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Transporters and Drug-Metabolizing Enzymes in Drug Toxicity by : Albert P. Li

Download or read book Transporters and Drug-Metabolizing Enzymes in Drug Toxicity written by Albert P. Li and published by John Wiley & Sons. This book was released on 2021-07-27 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: TRANSPORTERS AND DRUG-METABOLIZING ENZYMES IN DRUG TOXICITY Explore up-to-date coverage on the interaction between drug metabolism enzymes, transporters, and drug toxicity with this leading resources Transporters and Drug-Metabolizing Enzymes in Drug Toxicity delivers a comprehensive and updated review of the relationship between drug metabolism, transporters, and toxicity, providing insights into a major challenge in drug development – accurate assessment of human drug toxicity. Combining two disciplines frequently considered independently of one another, the book combines drug metabolism and toxicology with a focus on the role of biotransformation on drug toxicity and as a major factor for species and individual differences. Mechanism and species differences in drug metabolizing enzymes and transporters are discussed, as are the methods used to investigate the role of drug metabolizing enzymes and transporters in drug toxicity. Finally, the distinguished authors describe promising new experimental approaches to accurately assessing human drug toxicity via the consideration of human-specific drug metabolism in toxicity assays. In addition to topics as diverse as extended clearance models, experimental approaches for the estimation of DILI potential of drug candidates and roles of transporters in renal drug toxicity, readers will also enjoy the inclusion of such subjects as: A thorough overview of and introduction to drug metabolism and transporters and drug toxicity An exploration of drug metabolism enzymes and transporter activities as risk factors of marketed drugs associated with drug-induced fatalities A discussion of human-based in vitro experimental models for the evaluation of metabolism-dependent drug toxicity A treatment of mechanism-based experimental models for the evaluation of BSEP inhibition and DILI An examination of transporters and cochlea toxicity Perfect for scientists, students, and practitioners with interests in metabolism, toxicology, and drug development in the pharmaceutical industry, Transporters and Drug-Metabolizing Enzymes in Drug Toxicity will also earn a place in the libraries of medicinal chemists, pharmacologists, biochemists, toxicologists, and regulators in the pharmaceutical and health industries.

Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition

Author : Johan Gabrielsson
Publisher : CRC Press
ISBN 13 : 9789186274924
Total Pages : 926 pages
Book Rating : 4.2/5 (749 download)

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Book Synopsis Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition by : Johan Gabrielsson

Download or read book Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition written by Johan Gabrielsson and published by CRC Press. This book was released on 2001-11-30 with total page 926 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a revised and very expanded version of the previous second edition of the book. "Pharmacokinetic and Pharmacodynamic Data Analysis" provides an introduction into pharmacokinetic and pharmacodynamic concepts using simple illustrations and reasoning. It describes ways in which pharmacodynamic and pharmacodynamic theory may be used to give insight into modeling questions and how these questions can in turn lead to new knowledge. This book differentiates itself from other texts in this area in that it bridges the gap between relevant theory and the actual application of the theory to real life situations. The book is divided into two parts; the first introduces fundamental principles of PK and PD concepts, and principles of mathematical modeling, while the second provides case studies obtained from drug industry and academia. Topics included in the first part include a discussion of the statistical principles of model fitting, including how to assess the adequacy of the fit of a model, as well as strategies for selection of time points to be included in the design of a study. The first part also introduces basic pharmacokinetic and pharmacodynamic concepts, including an excellent discussion of effect compartment (link) models as well as indirect response models. The second part of the text includes over 70 modeling case studies. These include a discussion of the selection of the model, derivation of initial parameter estimates and interpretation of the corresponding output. Finally, the authors discuss a number of pharmacodynamic modeling situations including receptor binding models, synergy, and tolerance models (feedback and precursor models). This book will be of interest to researchers, to graduate students and advanced undergraduate students in the PK/PD area who wish to learn how to analyze biological data and build models and to become familiar with new areas of application. In addition, the text will be of interest to toxicologists interested in learning about determinants of exposure and performing toxicokinetic modeling. The inclusion of the numerous exercises and models makes it an excellent primary or adjutant text for traditional PK courses taught in pharmacy and medical schools. A diskette is included with the text that includes all of the exercises and solutions using WinNonlin.

Oral Drug Absorption

Author : Jennifer B. Dressman
Publisher : CRC Press
ISBN 13 : 1420077341
Total Pages : 432 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Oral Drug Absorption by : Jennifer B. Dressman

Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an

Biopharmaceutics Modeling and Simulations

Author : Kiyohiko Sugano
Publisher : John Wiley & Sons
ISBN 13 : 111835432X
Total Pages : 520 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Biopharmaceutics Modeling and Simulations by : Kiyohiko Sugano

Download or read book Biopharmaceutics Modeling and Simulations written by Kiyohiko Sugano and published by John Wiley & Sons. This book was released on 2012-07-31 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction to using modeling and simulation programs in drug discovery and development Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success. And while there are a number of commercially available software programs for drug modeling, there has not been a single resource guiding pharmaceutical professionals to the actual tools and practices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs, Biopharmaceutics Modeling and Simulations offers pharmaceutical scientists the keys to understanding how they work and are applied in creating drugs with desired medicinal properties. Beginning with a focus on the oral absorption of drugs, the book discusses: The central dogma of oral drug absorption (the interplay of dissolution, solubility, and permeability of a drug), which forms the basis of the biopharmaceutical classification system (BCS) The concept of drug concentration How to simulate key drug absorption processes The physiological and drug property data used for biopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerless examination of all the key aspects of drug research—including running and interpreting models, validation, and compound and formulation selection—this reference seamlessly brings together the proven practical approaches essential to developing the safe and effective medicines of tomorrow.

In Vitro-In Vivo Correlations

Author : David B. Young
Publisher : Springer Science & Business Media
ISBN 13 : 1468460366
Total Pages : 299 pages
Book Rating : 4.4/5 (684 download)

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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.

Basic Pharmacokinetics and Pharmacodynamics

Author : Sara E. Rosenbaum
Publisher : John Wiley & Sons
ISBN 13 : 1119143160
Total Pages : 576 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Basic Pharmacokinetics and Pharmacodynamics by : Sara E. Rosenbaum

Download or read book Basic Pharmacokinetics and Pharmacodynamics written by Sara E. Rosenbaum and published by John Wiley & Sons. This book was released on 2016-11-22 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated with new chapters and topics, this book provides a comprehensive description of all essential topics in contemporary pharmacokinetics and pharmacodynamics. It also features interactive computer simulations for students to experiment and observe PK/PD models in action. • Presents the essentials of pharmacokinetics and pharmacodynamics in a clear and progressive manner • Helps students better appreciate important concepts and gain a greater understanding of the mechanism of action of drugs by reinforcing practical applications in both the book and the computer modules • Features interactive computer simulations, available online through a companion website at: https://web.uri.edu/pharmacy/research/rosenbaum/sims/ • Adds new chapters on physiologically based pharmacokinetic models, predicting drug-drug interactions, and pharmacogenetics while also strengthening original chapters to better prepare students for more advanced applications • Reviews of the 1st edition: “This is an ideal textbook for those starting out … and also for use as a reference book …." (International Society for the Study of Xenobiotics) and “I could recommend Rosenbaum’s book for pharmacology students because it is written from a perspective of drug action . . . Overall, this is a well-written introduction to PK/PD …. “ (British Toxicology Society Newsletter)

Drug-Drug Interactions

Author : A. David Rodrigues
Publisher : CRC Press
ISBN 13 : 0849375940
Total Pages : 769 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Drug-Drug Interactions by : A. David Rodrigues

Download or read book Drug-Drug Interactions written by A. David Rodrigues and published by CRC Press. This book was released on 2019-01-03 with total page 769 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes

Pharmacokinetic-Pharmacodynamic Modeling and Simulation

Author : Peter L. Bonate
Publisher : Springer Science & Business Media
ISBN 13 : 1441994858
Total Pages : 618 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Pharmacokinetic-Pharmacodynamic Modeling and Simulation by : Peter L. Bonate

Download or read book Pharmacokinetic-Pharmacodynamic Modeling and Simulation written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2011-07-01 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a second edition to the original published by Springer in 2006. The comprehensive volume takes a textbook approach systematically developing the field by starting from linear models and then moving up to generalized linear and non-linear mixed effects models. Since the first edition was published the field has grown considerably in terms of maturity and technicality. The second edition of the book therefore considerably expands with the addition of three new chapters relating to Bayesian models, Generalized linear and nonlinear mixed effects models, and Principles of simulation. In addition, many of the other chapters have been expanded and updated.

Assessing the Human Health Risks of Trichloroethylene

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 9780309102834
Total Pages : 452 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Assessing the Human Health Risks of Trichloroethylene by : National Research Council

Download or read book Assessing the Human Health Risks of Trichloroethylene written by National Research Council and published by National Academies Press. This book was released on 2007-01-08 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trichloroethylene is a chlorinated solvent widely used as a degreasing agent in industrial and manufacturing settings. It is also used as a chemical intermediate in making other chemicals and is a component of products such as typewriter correction fluid, paint removers, adhesives, and spot removers. In 2001, EPA issued a draft health risk assessment and proposed exposure standards for trichloroethylene. PA's Scientific Advisory Board (SAB) reviewed the draft and it was issued for public comment. A number of scientific issues were raised during the course of these reviews. Assessing the Human Health Risks of Trichloroethylene identifies and assesses the key scientific issues relevant to analyzing the human health risks of trichloroethylene, considering pertinent toxicologic, epidemiologic, population susceptibility, and other available information, including relevant published scientific literature, EPA's 2001 draft health risk assessment of trichloroethylene, scientific and technical comments received by EPA from public and private sources, and additional relevant information to be provided by the sponsoring agencies. This report highlights issues critical to the development of an objective, realistic, and scientifically balanced trichloroethylene health risk assessment. Guidance for hazard characterization of trichloroethylene is presented in Chapters 2 through 10. Chapter 2 provides guidance for evaluating large sets of epidemiologic data. In Chapter 3, the committee applies this guidance as an example in its evaluation of the epidemiologic data on trichloroethylene and kidney cancer, and this example should help guide evaluations of other cancer risks. Chapter 3 also assesses new information on the kidney toxicity of trichloroethylene and its metabolites and potential modes of action. Chapters 4, 5, 6, 7, and 8 evaluate the key issues regarding liver toxicity and cancer, reproductive and developmental toxicity, neurotoxicity, respiratory tract toxicity and cancer, and immunotoxicity, respectively. However, the committee's review focused on mode-of-action information to understand how trichloroethylene might affect certain processes differently in different species. Chapter 9 discusses susceptibility to trichloroethylene and its metabolites, and Chapter 10 describes important factors in considering trichloroethylene in mixtures. Physiologically based pharmacokinetic models are evaluated in Chapter 11, and guidance is provided on future directions for model development. Finally, Chapter 12 considers issues related to dose-response assessment and quantitative assessment of risk.

Monte Carlo Simulation for the Pharmaceutical Industry

Author : Mark Chang
Publisher : CRC Press
ISBN 13 : 9781439835937
Total Pages : 564 pages
Book Rating : 4.8/5 (359 download)

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Book Synopsis Monte Carlo Simulation for the Pharmaceutical Industry by : Mark Chang

Download or read book Monte Carlo Simulation for the Pharmaceutical Industry written by Mark Chang and published by CRC Press. This book was released on 2010-09-29 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies. The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference. This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.

Handbook of Pharmaceutical Granulation Technology

Author : Dilip M. Parikh
Publisher : CRC Press
ISBN 13 : 1000366383
Total Pages : 905 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Handbook of Pharmaceutical Granulation Technology by : Dilip M. Parikh

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies