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.

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: 2020-06-04
ISBN 10: 0128185961
ISBN 13: 9780128185964
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

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.

Human Biomonitoring for Environmental Chemicals

Human Biomonitoring for Environmental Chemicals
Author: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Human Biomonitoring for Environmental Toxicants
Publsiher: National Academies Press
Total Pages: 316
Release: 2006-10-30
ISBN 10: 9780309133906
ISBN 13: 0309133904
Language: EN, FR, DE, ES & NL

Human Biomonitoring for Environmental Chemicals Book Review:

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.

New Technologies for Toxicity Testing

New Technologies for Toxicity Testing
Author: Michael Balls,Robert D. Combes,Nirmala Bhogal
Publsiher: Springer Science & Business Media
Total Pages: 258
Release: 2012-03-22
ISBN 10: 1461430550
ISBN 13: 9781461430551
Language: EN, FR, DE, ES & NL

New Technologies for Toxicity Testing Book Review:

The central theme running through this volume on New Technologies for Toxicity Testing is the development and application of advanced techniques for cell and tissue culture, as well as new markers and endpoints of toxicity, as alternatives to the traditional paradigm of relying on data from laboratory animal tests to undertake labelling and risk assessment. Of course, many of the techniques and methods described in this volume are in the early stages of development, and much work will be needed to ensure their further improvement, optimisation and validation. However, we are confident that this will be achieved and that, just as with the in vitro assays that were validated and granted regulatory acceptance over the last decade, these, and many other new, advanced methods, will likewise become part of the toxicologist’s improved toolbox for coping with increasingly stringent and numerous regulatory requirements and test chemicals, while placing less reliance on traditional testing paradigms.

Fundamentals of Pediatric Drug Dosing

Fundamentals of Pediatric Drug Dosing
Author: Iftekhar Mahmood,Gilbert Burckart
Publsiher: Springer
Total Pages: 146
Release: 2016-10-28
ISBN 10: 3319437542
ISBN 13: 9783319437545
Language: EN, FR, DE, ES & NL

Fundamentals of Pediatric Drug Dosing Book Review:

Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not ‘small adults’, and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.

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

Computational Toxicology

Computational Toxicology
Author: Brad Reisfeld,Arthur N. Mayeno
Publsiher: Unknown
Total Pages: 648
Release: 2013
ISBN 10: 9781627030595
ISBN 13: 162703059X
Language: EN, FR, DE, ES & NL

Computational Toxicology Book Review:

Rapid advances in computer science, biology, chemistry, and other disciplines are enabling powerful new computational tools and models for toxicology and pharmacology. These computational tools hold tremendous promise for advancing science, from streamlining drug efficacy and safety testing, to increasing the efficiency and effectiveness of risk assessment for environmental chemicals. Computational Toxicology provides biomedical and quantitative scientists with essential background, context, examples, useful tips, and an overview of current developments in the field. Divided into four sections, Volume I covers a wide array of methodologies and topics. Opening with an introduction to the field of computational toxicology and its current and potential applications, the volume continues with 'best practices' in mathematical and computational modeling, followed by chemoinformatics and the use of computational techniques and databases to predict chemical properties and toxicity, as well as an overview of molecular dynamics. The final section is a compilation of the key elements and main approaches used in pharmacokinetic and pharmacodynamic modeling, including the modeling of absorption, compartment and non-compartmental modeling, physiologically based pharmacokinetic modeling, interspecies extrapolation, and population effects. Written in the successful Methods in Molecular Biology series format where possible, chapters include introductions to their respective topics, lists of the materials and software tools used, methods, and notes on troubleshooting. Authoritative and easily accessible, Computational Toxicology will allow motivated readers to participate in this exciting field and undertake a diversity of realistic problems of interest.

Intracellular Delivery III

Intracellular Delivery III
Author: Aleš Prokop,Volkmar Weissig
Publsiher: Springer
Total Pages: 453
Release: 2016-10-31
ISBN 10: 3319435256
ISBN 13: 9783319435251
Language: EN, FR, DE, ES & NL

Intracellular Delivery III Book Review:

A critical review is attempted to assess the status of nanomedicine entry onto the market. The emergence of new potential therapeutic entities such as DNA and RNA fragments requires that these new “drugs” will need to be delivered in a cell-and organelle-specific manner. Although efforts have been made over the last 50 years or so to develop such delivery technology, no effective and above all clinically approved protocol for cell-specific drug delivery in humans exists as yet. Various particles, macromolecules, liposomes and most recently “nanomaterials” have been said to “show promise” but none of these promises have so far been “reduced” to human clinical practice. The focus of this volume is on cancer indication since the majority of published research relates to this application; within that, we focus on solid tumors (solid malignancies). Our aim is critically to evaluate whether nanomaterials, both non-targeted and targeted to specific cells, could be of therapeutic benefit in clinical practice. The emphasis of this volume will be on pharmacokinetics (PK) and pharmacodynamics (PD) in animal and human studies. Apart from the case of exquisitely specific antibody-based drugs, the development of target-specific drug–carrier delivery systems has not yet been broadly successful at the clinical level. It can be argued that drugs generated using the conventional means of drug development (i.e., relying on facile biodistribution and activity after (preferably) oral administration) are not suitable for a target-specific delivery and would not benefit from such delivery even when a seemingly perfect delivery system is available. Therefore, successful development of site-selective drug delivery systems will need to include not only the development of suitable carriers, but also the development of drug entities that meet the required PK/PD profile.

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.

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)

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases
Author: Honghui Zhou,Diane R. Mould
Publsiher: John Wiley & Sons
Total Pages: 496
Release: 2019-02-14
ISBN 10: 111928922X
ISBN 13: 9781119289227
Language: EN, FR, DE, ES & NL

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases Book Review:

Thorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed. Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include: • Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins • Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins) • Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.

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.

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:
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.

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.

Pharmaceutical Nanotechnology

Pharmaceutical Nanotechnology
Author: Jean Cornier
Publsiher: John Wiley & Sons
Total Pages: 775
Release: 2017-02-06
ISBN 10: 3527340548
ISBN 13: 9783527340545
Language: EN, FR, DE, ES & NL

Pharmaceutical Nanotechnology Book Review:

With its focus on concrete methods and recent advances in applying nanotechnology to develop new drug therapies and medical diagnostics, this book provides an overall picture of the field, from the fundamentals of nanopharmacy with the characterisation and manufacturing methods to the role of nanoparticles and substances. Actual examples of utilization include drug development issues, translation to the clinic, market prospects, and industrial commercialization aspects. The applications described are taken from cancer treatment as well as other major therapeutic areas, such as infectious diseases and dermatology. An in-depth discussion on safety, regulatory, and societal aspects rounds off the book. Written by a top team of editors and authors composed of the leading experts in Europe and the USA who have pioneered the field of nanopharmacy!

Transporters in Drug Development

Transporters in Drug Development
Author: Yuichi Sugiyama,Bente Steffansen
Publsiher: Springer Science & Business Media
Total Pages: 317
Release: 2013-09-16
ISBN 10: 1461482291
ISBN 13: 9781461482291
Language: EN, FR, DE, ES & NL

Transporters in Drug Development Book Review:

Transporters in Drug Development examines how membrane transporters can be dealt with in academic–industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. The book describes methods and examples of in vitro characterization of single transporters in the intestines, liver and kidneys as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters’ impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are explored, and the book highlights perspectives of applying targeted proteomics and mechanistic modeling in this process.