Physiologically Based Pharmacokinetic PBPK Modeling

Physiologically Based Pharmacokinetic  PBPK  Modeling
Author: Jeffrey W. Fisher,Jeffery M. Gearhart,Zhoumeng Lin
Publsiher: Academic Press
Total Pages: 346
Release: 2020-05-20
ISBN 10: 0128196823
ISBN 13: 9780128196823
Language: EN, FR, DE, ES & NL

Physiologically Based Pharmacokinetic PBPK Modeling Book Review:

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

Physiologically Based Pharmacokinetic PBPK Modeling and Simulations

Physiologically Based Pharmacokinetic  PBPK  Modeling and Simulations
Author: Sheila Annie Peters
Publsiher: John Wiley & Sons
Total Pages: 450
Release: 2012-02-17
ISBN 10: 1118140303
ISBN 13: 9781118140307
Language: EN, FR, DE, ES & NL

Physiologically Based Pharmacokinetic PBPK Modeling and Simulations Book Review:

The only book dedicated to physiologically-based pharmacokineticmodeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has becomeincreasingly widespread within the pharmaceutical industry over thelast decade, but without one dedicated book that provides theinformation researchers need to learn these new techniques, itsapplications are severely limited. Describing the principles,methods, and applications of PBPK modeling as used inpharmaceutics, Physiologically-Based Pharmacokinetic (PBPK)Modeling and Simulations fills this void. Connecting theory with practice, the book explores theincredible potential of PBPK modeling for improving drug discoveryand development. Comprised of two parts, the book first provides adetailed and systematic treatment of the principles behindphysiological modeling of pharmacokinetic processes,inter-individual variability, and drug interactions for smallmolecule drugs and biologics. The second part looks in greaterdetail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for abrief overview of the field as well as those who need more detail,the book includes a range of important learning aids. Featuringend-of-chapter keywords for easy reference—a valuable assetfor general or novice readers without a PBPK background—alongwith an extensive bibliography for those looking for furtherinformation, Physiologically- Based Pharmacokinetic (PBPK) Modelingand Simulations is the essential single-volume text on one of thehottest topics in the pharmaceutical sciences today.

Physiologically Based Pharmacokinetic Modeling

Physiologically Based Pharmacokinetic Modeling
Author: Micaela Reddy,R. S. Yang,Melvin E. Andersen,Harvey J. Clewell III
Publsiher: John Wiley & Sons
Total Pages: 420
Release: 2005-06-14
ISBN 10: 0471478776
ISBN 13: 9780471478775
Language: EN, FR, DE, ES & NL

Physiologically Based Pharmacokinetic Modeling Book Review:

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.

Pharmacokinetic and Pharmacodynamic Data Analysis Concepts and Applications Third Edition

Pharmacokinetic and Pharmacodynamic Data Analysis  Concepts and Applications  Third Edition
Author: Johan Gabrielsson,Daniel Weiner
Publsiher: CRC Press
Total Pages: 924
Release: 2001-11-30
ISBN 10: 9789186274924
ISBN 13: 9186274929
Language: EN, FR, DE, ES & NL

Pharmacokinetic and Pharmacodynamic Data Analysis Concepts and Applications Third Edition Book Review:

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.

Metabolite Safety in Drug Development

Metabolite Safety in Drug Development
Author: Suzanne L. Iverson
Publsiher: John Wiley & Sons
Total Pages: 352
Release: 2016-08-01
ISBN 10: 111894965X
ISBN 13: 9781118949658
Language: EN, FR, DE, ES & NL

Metabolite Safety in Drug Development Book Review:

A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA. • Reviews the analytical techniques and experimental designs critical for metabolite studies • Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation • Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions • Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines

Acute Exposure Guideline Levels for Selected Airborne Chemicals

Acute Exposure Guideline Levels for Selected Airborne Chemicals
Author: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Toxicology,Committee on Acute Exposure Guideline Levels
Publsiher: National Academies Press
Total Pages: 462
Release: 2009-09-30
ISBN 10: 9780309162661
ISBN 13: 0309162661
Language: EN, FR, DE, ES & NL

Acute Exposure Guideline Levels for Selected Airborne Chemicals Book Review:

This book is the ninth volume in the series Acute Exposure Guideline Levels for Selected Airborne Chemicals, and reviews AEGLs for bromine, ethylene oxide, furan, hydrogen sulfide, propylene oxide, and xylenes.

Ecotoxicology Modeling

Ecotoxicology Modeling
Author: James Devillers
Publsiher: Springer Science & Business Media
Total Pages: 412
Release: 2009-08-07
ISBN 10: 9781441901972
ISBN 13: 1441901973
Language: EN, FR, DE, ES & NL

Ecotoxicology Modeling Book Review:

Ecotoxicology Modeling is a comprehensive and well-documented text providing a collection of computational methods to the ecotoxicologists primarily interested in the study of the adverse effects of chemicals, their mechanisms of action and/or their environmental fate and behavior. Avoiding mathematical jargon, the book presents numerous case studies to enable the reader to understand the interest but also the limitations of linear and nonlinear models in ecotoxicology. Written by an international team of scientists, Ecotoxicology Modeling is of primary interest to those whose research or professional activity is directly concerned with the development and application of models in ecotoxicology. It is also intended to provide the graduate and post-graduate students with a clear and accessible text covering the main types of modeling approaches used in environmental sciences.

Assessing the Human Health Risks of Trichloroethylene

Assessing the Human Health Risks of Trichloroethylene
Author: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Human Health Risks of Trichloroethylene
Publsiher: National Academies Press
Total Pages: 448
Release: 2007-01-08
ISBN 10: 9780309102834
ISBN 13: 0309102839
Language: EN, FR, DE, ES & NL

Assessing the Human Health Risks of Trichloroethylene Book Review:

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.

Translational Physiologically based Pharmacokinetic PBPK Modeling and Simulation to Support Drug Development and Pharmacotherapy

Translational Physiologically based Pharmacokinetic  PBPK  Modeling and Simulation to Support Drug Development and Pharmacotherapy
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2018
ISBN 10: 1928374650XXX
ISBN 13: OCLC:1043906419
Language: EN, FR, DE, ES & NL

Translational Physiologically based Pharmacokinetic PBPK Modeling and Simulation to Support Drug Development and Pharmacotherapy Book Review:

Pharmacokinetics of Drugs

Pharmacokinetics of Drugs
Author: Peter G. Welling,Luc P. Balant
Publsiher: Springer Science & Business Media
Total Pages: 537
Release: 2012-12-06
ISBN 10: 3642786804
ISBN 13: 9783642786808
Language: EN, FR, DE, ES & NL

Pharmacokinetics of Drugs Book Review:

A compilation of researchers' experience in the areas of bioanalysis, pharmacokinetics, and drug metabolism, to present an up-to-date and comprehensive treatise on the application of these and related technologies in drug discovery, development, and clinical use. Contents cover descriptions of analytical methods, in vitro metabolism technology and membrane transport, reappraisal of classical pharmacokinetic problems, and the time course of drug action. The book concludes with a description of PET and imaging methods in pharmacokinetics and an appendix containing a critical appraisal of computer methods and pharmacokinetic software available for PCs.

Quantitative Modeling in Toxicology

Quantitative Modeling in Toxicology
Author: Kannan Krishnan,Melvin E. Andersen
Publsiher: John Wiley & Sons
Total Pages: 504
Release: 2010-04-01
ISBN 10: 0470686707
ISBN 13: 9780470686706
Language: EN, FR, DE, ES & NL

Quantitative Modeling in Toxicology Book Review:

Governments around the world are passing laws requiring industry to assess the toxicity of the chemicals and products they produce, but to do so while reducing, refining, or even replacing testing on animals. To meet these requirements, experimental toxicologists and risk assessors are adopting quantitative approaches and computer simulations to study the biological fate and effects of chemicals and drugs. In Quantitative Modeling in Toxicology leading experts outline the current state of knowledge on the modeling of dose, tissue interactions and tissue responses. Each chapter describes the mathematical foundation, parameter estimation, challenges and perspectives for development, along with the presentation of a modeling template. Additionally, tools and approaches for conducting uncertainty, sensitivity and variability analyses in these models are described. Topics covered include: the quantitative models of pharmacokinetics of individual chemicals and mixtures models for toxicant-target tissue interaction. models for cellular, organ, and organism responses. approaches, tools and challenges for model application and evaluation A website containing computer codes accompanies the book to help the reader reconstruct the models described and discussed in the various chapters. Quantitative Modeling in Toxicology serves as an essential reference source and tool box for risk assessors and researchers and students in toxicology, public health, pharmacology, and human toxicology interested in developing quantitative models for a better understanding of dose-response relationships.

Toxicokinetics and Risk Assessment

Toxicokinetics and Risk Assessment
Author: John C. Lipscomb,Edward V. Ohanian
Publsiher: CRC Press
Total Pages: 361
Release: 2016-04-19
ISBN 10: 1000612139
ISBN 13: 9781000612134
Language: EN, FR, DE, ES & NL

Toxicokinetics and Risk Assessment Book Review:

Toxicokinetics in Risk Assessment discusses the noncancer risk assessment process and its reliance on uncertainty factors in order to facilitate the continued study and refinement of the scientific basis for health risk assessment. This text clearly demonstrates the application of physiologically-based pharmacokinetic (PBPK) modeling in human healt

Basic Pharmacokinetics and Pharmacodynamics

Basic Pharmacokinetics and Pharmacodynamics
Author: Sara E. Rosenbaum
Publsiher: John Wiley & Sons
Total Pages: 576
Release: 2016-11-22
ISBN 10: 1119143160
ISBN 13: 9781119143161
Language: EN, FR, DE, ES & NL

Basic Pharmacokinetics and Pharmacodynamics Book Review:

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)

Dermatotoxicology

Dermatotoxicology
Author: Hongbo Zhai,Howard I. Maibach
Publsiher: CRC Press
Total Pages: 1232
Release: 2004-02-25
ISBN 10: 9780203426272
ISBN 13: 0203426274
Language: EN, FR, DE, ES & NL

Dermatotoxicology Book Review:

For twenty-five years, Dermatotoxicology has stood as the definitive reference book in the field. A generation of toxicologists and dermatologists has consulted this volume throughout their careers, finding within it a wealth of theoretical and practical guidance. Updated and expanded to reflect the latest developments in skin toxicology, De

Biopharmaceutics Applications in Drug Development

Biopharmaceutics Applications in Drug Development
Author: Rajesh Krishna,Lawrence Yu
Publsiher: Springer Science & Business Media
Total Pages: 396
Release: 2007-09-20
ISBN 10: 038772379X
ISBN 13: 9780387723792
Language: EN, FR, DE, ES & NL

Biopharmaceutics Applications in Drug Development Book Review:

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

21st European Symposium on Computer Aided Process Engineering

21st European Symposium on Computer Aided Process Engineering
Author: E. N. Pistikopoulos,M. C. Georgiadis,A. C. Kokossis
Publsiher: Elsevier
Total Pages: 2029
Release: 2011-05-26
ISBN 10: 044453895X
ISBN 13: 9780444538956
Language: EN, FR, DE, ES & NL

21st European Symposium on Computer Aided Process Engineering Book Review:

The European Symposium on Computer Aided Process Engineering (ESCAPE) series presents the latest innovations and achievements of leading professionals from the industrial and academic communities. The ESCAPE series serves as a forum for engineers, scientists, researchers, managers and students to present and discuss progress being made in the area of Computer Aided Process Engineering (CAPE). European industries large and small are bringing innovations into our lives, whether in the form of new technologies to address environmental problems, new products to make our homes more comfortable and energy efficient or new therapies to improve the health and well-being of European citizens. Moreover, the European Industry needs to undertake research and technological initiatives in response to humanity's "Grand Challenges", described in the declaration of Lund, namely, Global Warming, Tightening Supplies of Energy, Water and Food, Ageing Societies, Public Health, Pandemics and Security. Thus, the Technical Theme of ESCAPE 21 will be "Process Systems Approaches for Addressing Grand Challenges in Energy, Environment, Health, Bioprocessing & Nanotechnologies".

Value Creation in the Pharmaceutical Industry

Value Creation in the Pharmaceutical Industry
Author: Alexander Schuhmacher,Markus Hinder,Oliver Gassmann
Publsiher: John Wiley & Sons
Total Pages: 508
Release: 2016-04-11
ISBN 10: 3527339132
ISBN 13: 9783527339136
Language: EN, FR, DE, ES & NL

Value Creation in the Pharmaceutical Industry Book Review:

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Drug Transporters

Drug Transporters
Author: Martin F. Fromm,Richard B. Kim
Publsiher: Springer Science & Business Media
Total Pages: 454
Release: 2010-11-19
ISBN 10: 9783642145414
ISBN 13: 3642145418
Language: EN, FR, DE, ES & NL

Drug Transporters Book Review:

It is increasingly recognized that various transporter proteins are expressed throughout the body and determine absorption, tissue distribution, biliary and renal elimination of endogenous compounds and drugs and drug effects. This book will give an overview on the transporter families which are most important for drug therapy. Most chapters will focus on one transporter family highlighting tissue expression, substrates, inhibitors, knock-out mouse models and clinical studies.

Physiologically Based Pharmacokinetic Toxicokinetic Modeling in Risk Assessment

Physiologically Based Pharmacokinetic Toxicokinetic Modeling in Risk Assessment
Author: Anonim
Publsiher: Unknown
Total Pages: 40
Release: 2005
ISBN 10: 1928374650XXX
ISBN 13: OCLC:64439235
Language: EN, FR, DE, ES & NL

Physiologically Based Pharmacokinetic Toxicokinetic Modeling in Risk Assessment Book Review:

Physiologically-based pharmacokinetic (PBPK) modeling has become the tool of choice to develop estimates of target site dosimetries in animals and humans for risk assessment purposes. PBPK model compartments correspond directly to the tissues and organs in the species. The drawbacks of PBPK modeling primarily relate to the time, effort and cost involved in appropriately developing, validating and applying a model. We outline some of the practical issues involved in the appropriate development of a PBPK model. Among the first models to be developed and used for risk assessment were those for volatile organics. These basic models are discussed in this report. For some chemicals, however, simpler models are not enough to adequately describe the data. We discuss some of the issues involved in the development of more complex PBPK models. Issues may include more detailed modeling of metabolic processes and specific organs; changes in physiology due to development, pregnancy or aging (life-stage modeling); and interactions between more than one chemical. It may also be necessary to interface the pharmacokinetic models with models of the interaction of the chemical with the target tissue (pharmacodynamic PD models) in order to provide a more complete description of the overall process. Certain experimental techniques are central to the successful development of PBPK models. These include methods to experimentally determine blood and tissue partition coefficients, metabolic parameters, and exposure kinetics.

Neurobiology of Cerebrospinal Fluid 1

Neurobiology of Cerebrospinal Fluid 1
Author: James H. Wood
Publsiher: Springer Science & Business Media
Total Pages: 768
Release: 2013-06-29
ISBN 10: 1468410393
ISBN 13: 9781468410396
Language: EN, FR, DE, ES & NL

Neurobiology of Cerebrospinal Fluid 1 Book Review:

Physiologic compartmentalization effectively isolates the central nervous system from the rest of the body. This isolation not only provides protection of its delicate function from aberrant peripheral influences but also impedes its diagnostic evaluation. Cerebro spinal fluid (CSF) bathes the brain and spinal cord, is in dynamic equilibrium with its extracellular fluid, and tends to reflect the state of health and activity of the central nervous system. CSF examination is the most direct and popular method of assessing the central chemical and cellular environment in the living patient or mammal. The purpose of this multidisciplined reference text is to provide the sophisticated knowledge of CSF physiology and pathology necessary for the meaningful interpretation of data obtained by various types of CSF analysis. The methodology for reliable CSF collection, storage, preparation, and analysis is discussed with respect to individual, somatotropic, chronologic, endorcinologic, pharmacologic, and possible artifactual var iations in CSF composition. These essential aspects, which ensure the validity of CSF data, are presented to aid the investigator in clinical and experimental protocol formu lation and in elimination of possible sources of error.