Applied Pharmacometrics

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Applied Pharmacometrics

Author : Stephan Schmidt
Publisher : Springer
ISBN 13 : 1493913042
Total Pages : 570 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Applied Pharmacometrics by : Stephan Schmidt

Download or read book Applied Pharmacometrics written by Stephan Schmidt and published by Springer. This book was released on 2014-12-01 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer’s disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.

Pharmacometrics

Author : Ene I. Ette
Publisher : John Wiley & Sons
ISBN 13 : 1118679512
Total Pages : 1236 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Pharmacometrics by : Ene I. Ette

Download or read book Pharmacometrics written by Ene I. Ette and published by John Wiley & Sons. This book was released on 2013-03-14 with total page 1236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.

Applied Clinical Pharmacokinetics 3/E

Author : Larry A. Bauer
Publisher : McGraw Hill Professional
ISBN 13 : 007179459X
Total Pages : 881 pages
Book Rating : 4.0/5 (717 download)

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Book Synopsis Applied Clinical Pharmacokinetics 3/E by : Larry A. Bauer

Download or read book Applied Clinical Pharmacokinetics 3/E written by Larry A. Bauer and published by McGraw Hill Professional. This book was released on 2014-01-05 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: The most current, hands-on book in the field, Applied Clinical Pharmacokinetics The perfect textbook for pharmacy students learning the clinical application of pharmacokinetics, which is the mathematical tools for modifying doages. Students like that each chapter includes sample problems throughout the chapter, with a ton of practice problems at the end. Answers for the practice problems are in the back, but not detailed like the sample problems) *Changes in the 3/e includes: *All chapters updated and revised, as needed, including critical new references *Antibiotic individualization and monitoring sections increases use of pharmacodynamic parameters (Cmax/MIC, AUC24/MIC, Time above MIC) in addition to pharmacokinetic parameters to adjust dosages *Anticonvulsants section includes 5 new agents (Fosphenytoin, Lamotrigine, Levetiracetam, Oxcarbazepine, Eslicarbazepine) *Immunosuppressants section includes 1 new agent (Sirolimus), About the Book Text focuses on the latest standardized techniques and approaches to patient-specific dosing and provides up-to-date information on more recently moniotored drugs. Features Clear, useful coverage of drug dosing and drug monitoring Clear and concise summary of pharmacokinetic and pharmacodynamic concepts Practical help with calculations and equations Focus on the latest standardized techniques and approaches to patient-specific dosing Up-to-date information on more recently monitored drugs Essential information on drug dosing in special populations, including patients with renal and hepatic disease, obesity, and congestive heart failure All the information practitioners need on drug categories such as antibiotics, cardiovascular agents, anticonvulsants, and immunosuppressants Full coverage of drugs such as Aminoglycosides, Vancomycin, Digoxin, Phenytoin, Carbamazepine, Theophylline, Cyclosporine, Tacrolimus, and Lithium Student friendly approach to teaching pharmacokinetics--sample problems embedded into the text to allow for students to apply what they are learing. .

Pharmacokinetic-Pharmacodynamic Modeling and Simulation

Author : Peter L. Bonate
Publisher : Springer Science & Business Media
ISBN 13 : 1441994858
Total Pages : 634 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 634 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.

Applied Clinical Pharmacokinetics

Author : Larry A. Bauer
Publisher : McGraw Hill Professional
ISBN 13 : 0071593721
Total Pages : 842 pages
Book Rating : 4.0/5 (715 download)

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Book Synopsis Applied Clinical Pharmacokinetics by : Larry A. Bauer

Download or read book Applied Clinical Pharmacokinetics written by Larry A. Bauer and published by McGraw Hill Professional. This book was released on 2007-09-22 with total page 842 pages. Available in PDF, EPUB and Kindle. Book excerpt: New sections on dosing strategies in all chapters. New chapter on sirolimus under the Immunosuppressants section. Essential information on drug dosing in special populations, including patients with renal and hepatic disease, obesity, and congestive heart failure. 30% of chapters extensively revised, others lightly updated

Mathematical Modeling of Pharmacokinetic Data

Author : DavidW.A. Bourne
Publisher : Routledge
ISBN 13 : 1351433245
Total Pages : 154 pages
Book Rating : 4.3/5 (514 download)

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Book Synopsis Mathematical Modeling of Pharmacokinetic Data by : DavidW.A. Bourne

Download or read book Mathematical Modeling of Pharmacokinetic Data written by DavidW.A. Bourne and published by Routledge. This book was released on 2018-05-02 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise guide to mathematical modeling and analysis of pharmacokinetic data, this book contains valuable methods for maximizing the information obtained from given data. It is an ideal resource for scientists, scholars, and advanced students.

Basic Pharmacokinetics and Pharmacodynamics

Author : Sara E. Rosenbaum
Publisher : John Wiley & Sons
ISBN 13 : 111819778X
Total Pages : 440 pages
Book Rating : 4.1/5 (181 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 2012-09-10 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its clear, straightforward presentation, this text enables you to grasp all the fundamental concepts of pharmacokinetics and pharmacodynamics. This will allow you to understand the time course of drug response and dosing regimen design. Clinical models for concentration and response are described and built from the basic concepts presented in earlier chapters. Your understanding of the material will be enhanced by guided computer exercises conducted on a companion website. Simulations will allow you to visualize drug behavior, experiment with different dosing regimens, and observe the influence of patient characteristics and model parameters. This makes the book ideal for self-study. By including clinical models of agonism, indirect drug effects, tolerance, signal transduction, and disease progression, author Sara Rosenbaum has created a work that stands out among introductory-level textbooks in this area.You'll find several features throughout the text to help you better understand and apply key concepts: Three fictitious drugs are used throughout the text to progressively illustrate the development and application of pharmacokinetic and pharmacodynamic principles Exercises at the end of each chapter reinforce the concepts and provide the opportunity to perform and solve common dosing problems Detailed instructions let you create custom Excel worksheets to perform simple pharmacokinetic analyses Because this is an introductory textbook, the material is presented as simply as possible. As a result, you'll find it easy to gain an accurate, working knowledge of all the core principles, apply them to optimize dosing regimens, and evaluate the clinical pharmacokinetic and pharmacodynamic literature.

Clinical Trial Simulations

Author : Holly H. C. Kimko
Publisher : Springer Science & Business Media
ISBN 13 : 1441974156
Total Pages : 540 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Clinical Trial Simulations by : Holly H. C. Kimko

Download or read book Clinical Trial Simulations written by Holly H. C. Kimko and published by Springer Science & Business Media. This book was released on 2010-12-09 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications

Author : Hartmut Derendorf
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 1496385896
Total Pages : 864 pages
Book Rating : 4.4/5 (963 download)

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Book Synopsis Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications by : Hartmut Derendorf

Download or read book Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications written by Hartmut Derendorf and published by Lippincott Williams & Wilkins. This book was released on 2019-07-11 with total page 864 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated with the latest clinical advances, Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics, Fifth Edition , explains the relationship between drug administration and drug response, taking a conceptual approach that emphasizes clinical application rather than science and mathematics. Bringing a real-life perspective to the topic, the book simplifies concepts and gives readers the knowledge they need to better evaluate drug applications.

Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics

Author : Alexander A. Vinks
Publisher : Springer Science & Business Media
ISBN 13 : 0387756132
Total Pages : 467 pages
Book Rating : 4.3/5 (877 download)

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Book Synopsis Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics by : Alexander A. Vinks

Download or read book Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics written by Alexander A. Vinks and published by Springer Science & Business Media. This book was released on 2013-11-23 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past decade, significant progress has been made in the theory and applications of pharmacodynamics of antimicrobial agents. On the basis of pharmacokinetic-pharmacodynamic modeling concepts it has become possible to describe and predict the time course of antimicrobial effects under normal and pathophysiological conditions. The study of pharmacokinetic-pharmacodynamic relationships can be of considerable value in understanding drug action, defining optimal dosing regimens, and in making predictions under new or changing pre-clinical and clinical circumstances. Not surprisingly, pharmacokinetic-pharmacodynamic modeling concepts are increasingly applied in both basic and clinical research as well as in drug development. The book will be designed as a reference on the application of pharmacokinetic-pharmacodynamic principles for the optimization of antimicrobial therapy, namely pharmacotherapy, and infectious diseases. The reader will be introduced to various aspects of the fundamentals of antimicrobial pharmacodynamics, the integration of pharmacokinetics with pharmacodynamics for all major classes of antibiotics, and the translation of in vitro and animal model data to basic research and clinical situations in humans.

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.

The Art and Science of Physiologically-Based Pharmacokinetics Modeling

Author : Rodrigo Cristofoletti
Publisher : CRC Press
ISBN 13 : 1040033121
Total Pages : 357 pages
Book Rating : 4.0/5 (4 download)

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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

Pharmacokinetics

Author : Peter G. Welling
Publisher :
ISBN 13 :
Total Pages : 312 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Pharmacokinetics by : Peter G. Welling

Download or read book Pharmacokinetics written by Peter G. Welling and published by . This book was released on 1986 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:

An Information-Theoretic Approach To High-Dimensional Pharmacometrics

Author : Jonathan Knights
Publisher :
ISBN 13 :
Total Pages : 304 pages
Book Rating : 4.:/5 (9 download)

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Book Synopsis An Information-Theoretic Approach To High-Dimensional Pharmacometrics by : Jonathan Knights

Download or read book An Information-Theoretic Approach To High-Dimensional Pharmacometrics written by Jonathan Knights and published by . This book was released on 2013 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: The following dissertation develops an information-theoretic computational framework, and shows applications for analysis of high-dimensional datasets such as those routinely encountered when conducting pharmacogenetic/genomic clinical trials. The successful application of information-theoretic concepts in pharmaceutical datasets provides a novel set of pharmacometric tools that may be leveraged to increase learning on genome scale datasets. A series of novel algorithms coded in the javaTM programming language with computational roots in information theory were extended and utilized as the basis for the methodology. Simulations and actual clinical datasets representing a broad range of complexity were utilized to highlight the capabilities of the computational approach on high-dimensional datasets. Additionally, the work was compared to existing methodologies on both theoretical and practical levels.^The results suggest that an information-theoretic analytical platform offers an appropriately flexible and computationally efficient basis for performing interaction analyses on high-dimensional data sets. In most cases, the proposed methods performed comparably to, or better than, existing methodologies when the size of the data set was not prohibitive for traditional approaches: These results held across all levels of complexity, and for clinical data as well simulated data. In situations where multiple types of relationships may exist and there is no specific need for a structural parameterization, the information-theoretic approach proposed here may serve as an appropriate analytical platform, capable of detecting novel interactions and informative relationships.^The algorithms that have been extended here are computationally efficient enough to allow detection of higher-order relationships in genome-scale data sets on common laboratory computers, negating the need for access to sophisticated computational facilities. Thus, the advancements realized by this work are as much theoretical as they are practical.

Translational Biomedical Informatics

Author : Bairong Shen
Publisher : Springer
ISBN 13 : 9811015031
Total Pages : 331 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Translational Biomedical Informatics by : Bairong Shen

Download or read book Translational Biomedical Informatics written by Bairong Shen and published by Springer. This book was released on 2016-10-31 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces readers to essential methods and applications in translational biomedical informatics, which include biomedical big data, cloud computing and algorithms for understanding omics data, imaging data, electronic health records and public health data. The storage, retrieval, mining and knowledge discovery of biomedical big data will be among the key challenges for future translational research. The paradigm for precision medicine and healthcare needs to integratively analyze not only the data at the same level – e.g. different omics data at the molecular level – but also data from different levels – the molecular, cellular, tissue, clinical and public health level. This book discusses the following major aspects: the structure of cross-level data; clinical patient information and its shareability; and standardization and privacy. It offers a valuable guide for all biologists, biomedical informaticians and clinicians with an interest in Precision Medicine Informatics.

Benefit-Risk Assessment Methods in Medical Product Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 1482259370
Total Pages : 296 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Benefit-Risk Assessment Methods in Medical Product Development by : Qi Jiang

Download or read book Benefit-Risk Assessment Methods in Medical Product Development written by Qi Jiang and published by CRC Press. This book was released on 2017-12-19 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

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.