Physiologically Based Pharmacokinetic Pbpk Modeling

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Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations

Sheila Annie Peters
Physiologically Based Pharmacokinetic PBPK Modeling and Simulations Book PDF

Author : Sheila Annie Peters
Publisher : John Wiley & Sons
Page : 399 pages
File Size : 41,9 Mb
Release : 2012-02-17
Category : Medical
ISBN : 9781118140307

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Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations by Sheila Annie Peters Pdf

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

Jeffrey W. Fisher,Jeffery M. Gearhart,Zhoumeng Lin
Physiologically Based Pharmacokinetic PBPK Modeling Book PDF

Author : Jeffrey W. Fisher,Jeffery M. Gearhart,Zhoumeng Lin
Publisher : Academic Press
Page : 348 pages
File Size : 47,7 Mb
Release : 2020-05-20
Category : Medical
ISBN : 9780128196823

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Physiologically Based Pharmacokinetic (PBPK) Modeling by Jeffrey W. Fisher,Jeffery M. Gearhart,Zhoumeng Lin Pdf

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 Modeling

Micaela Reddy,R. S. Yang,Melvin E. Andersen,Harvey J. Clewell III
Physiologically Based Pharmacokinetic Modeling Book PDF

Author : Micaela Reddy,R. S. Yang,Melvin E. Andersen,Harvey J. Clewell III
Publisher : John Wiley & Sons
Page : 420 pages
File Size : 49,7 Mb
Release : 2005-06-14
Category : Science
ISBN : 9780471478775

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Physiologically Based Pharmacokinetic Modeling by Micaela Reddy,R. S. Yang,Melvin E. Andersen,Harvey J. Clewell III Pdf

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 and Simulations

Sheila Annie Peters
Physiologically Based Pharmacokinetic PBPK Modeling and Simulations Book PDF

Author : Sheila Annie Peters
Publisher : John Wiley & Sons
Page : 644 pages
File Size : 45,7 Mb
Release : 2021-10-12
Category : Medical
ISBN : 9781119497684

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Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations by Sheila Annie Peters Pdf

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.

Human Biomonitoring for Environmental Chemicals

National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Human Biomonitoring for Environmental Toxicants
Human Biomonitoring for Environmental Chemicals Book PDF

Author : National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Human Biomonitoring for Environmental Toxicants
Publisher : National Academies Press
Page : 316 pages
File Size : 54,6 Mb
Release : 2006-10-30
Category : Science
ISBN : 9780309133906

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Human Biomonitoring for Environmental Chemicals by National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Human Biomonitoring for Environmental Toxicants Pdf

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

Bret Berner,Toufigh Gordi,Heather A. E. Benson,Michael S. Roberts
Drug Delivery Approaches Book PDF

Author : Bret Berner,Toufigh Gordi,Heather A. E. Benson,Michael S. Roberts
Publisher : John Wiley & Sons
Page : 466 pages
File Size : 42,8 Mb
Release : 2021-08-04
Category : Medical
ISBN : 9781119772750

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Drug Delivery Approaches by Bret Berner,Toufigh Gordi,Heather A. E. Benson,Michael S. Roberts Pdf

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.

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

Johan Gabrielsson,Daniel Weiner
Pharmacokinetic and Pharmacodynamic Data Analysis Concepts and Applications Third Edition Book PDF

Author : Johan Gabrielsson,Daniel Weiner
Publisher : CRC Press
Page : 926 pages
File Size : 47,6 Mb
Release : 2001-11-30
Category : Medical
ISBN : 9186274929

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Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition by Johan Gabrielsson,Daniel Weiner Pdf

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

Jennifer B. Dressman,Christos Reppas
Oral Drug Absorption Book PDF

Author : Jennifer B. Dressman,Christos Reppas
Publisher : CRC Press
Page : 432 pages
File Size : 54,8 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420077346

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Oral Drug Absorption by Jennifer B. Dressman,Christos Reppas Pdf

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

Transporters and Drug-Metabolizing Enzymes in Drug Toxicity

Albert P. Li
Transporters and Drug Metabolizing Enzymes in Drug Toxicity Book PDF

Author : Albert P. Li
Publisher : John Wiley & Sons
Page : 530 pages
File Size : 53,8 Mb
Release : 2021-07-27
Category : Medical
ISBN : 9781119170846

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Transporters and Drug-Metabolizing Enzymes in Drug Toxicity by Albert P. Li Pdf

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.

Biopharmaceutics

Hannah Batchelor
Biopharmaceutics Book PDF

Author : Hannah Batchelor
Publisher : John Wiley & Sons
Page : 324 pages
File Size : 51,5 Mb
Release : 2021-12-20
Category : Medical
ISBN : 9781119678281

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Biopharmaceutics by Hannah Batchelor Pdf

Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.

Toxicokinetics and Risk Assessment

John C. Lipscomb,Edward V. Ohanian
Toxicokinetics and Risk Assessment Book PDF

Author : John C. Lipscomb,Edward V. Ohanian
Publisher : CRC Press
Page : 388 pages
File Size : 49,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781000612134

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Toxicokinetics and Risk Assessment by John C. Lipscomb,Edward V. Ohanian Pdf

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

Drug-Drug Interactions

A. David Rodrigues
Drug Drug Interactions Book PDF

Author : A. David Rodrigues
Publisher : CRC Press
Page : 769 pages
File Size : 52,6 Mb
Release : 2019-01-03
Category : Medical
ISBN : 9780849375941

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Drug-Drug Interactions by A. David Rodrigues Pdf

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

Physics, Pharmacology and Physiology for Anaesthetists

Matthew E. Cross,Emma V. E. Plunkett
Physics Pharmacology and Physiology for Anaesthetists Book PDF

Author : Matthew E. Cross,Emma V. E. Plunkett
Publisher : Cambridge University Press
Page : 439 pages
File Size : 47,7 Mb
Release : 2014-03-06
Category : Medical
ISBN : 9781107615885

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Physics, Pharmacology and Physiology for Anaesthetists by Matthew E. Cross,Emma V. E. Plunkett Pdf

A quick reference to basic science for anaesthetists, containing all the key information needed for FRCA exams.

In Vitro-In Vivo Correlations

David B. Young,John G. Devane,Jackie Butler
In Vitro In Vivo Correlations Book PDF

Author : David B. Young,John G. Devane,Jackie Butler
Publisher : Springer Science & Business Media
Page : 299 pages
File Size : 44,5 Mb
Release : 2013-03-08
Category : Medical
ISBN : 9781468460360

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In Vitro-In Vivo Correlations by David B. Young,John G. Devane,Jackie Butler Pdf

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.

Biopharmaceutics Modeling and Simulations

Kiyohiko Sugano
Biopharmaceutics Modeling and Simulations Book PDF

Author : Kiyohiko Sugano
Publisher : John Wiley & Sons
Page : 520 pages
File Size : 47,6 Mb
Release : 2012-07-31
Category : Medical
ISBN : 9781118354322

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Biopharmaceutics Modeling and Simulations by Kiyohiko Sugano Pdf

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.