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.
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 2006-05-14 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: A natural hierarchy exists in pharmacokinetic-pharmacodynamic modeling culminating in population pharmacokinetic models, which are a specific type of nonlinear mixed effects model. The purpose of this book is to present through theory and example how to develop pharmacokinetic models, both at an individual and population level. In order to do so, however, one must first understand linear models and then build to nonlinear models followed by linear mixed effects models and then ultimately nonlinear mixed effects models. This book develops in that manner – each chapter builds upon previous chapters by first presenting the theory and then illustrating the theory using published data sets and actual data sets that were used in the development of new chemical entities collected by the author during his years in industry. A key feature of the book is the process of modeling. Most books and manuscripts often present the final model never showing how the model evolved. In this book all examples are presented in an evolutionary manner.
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 2005-10-20 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: A natural hierarchy exists in pharmacokinetic-pharmacodynamic modeling culminating in population pharmacokinetic models, which are a specific type of nonlinear mixed effects model. The purpose of this book is to present through theory and example how to develop pharmacokinetic models, both at an individual and population level. In order to do so, however, one must first understand linear models and then build to nonlinear models followed by linear mixed effects models and then ultimately nonlinear mixed effects models. This book develops in that manner – each chapter builds upon previous chapters by first presenting the theory and then illustrating the theory using published data sets and actual data sets that were used in the development of new chemical entities collected by the author during his years in industry. A key feature of the book is the process of modeling. Most books and manuscripts often present the final model never showing how the model evolved. In this book all examples are presented in an evolutionary manner.
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.
Download or read book Simulation for Designing Clinical Trials written by Hui Kimko and published by CRC Press. This book was released on 2002-12-12 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation p
Download or read book Modeling in Biopharmaceutics Pharmacokinetics and Pharmacodynamics written by Panos Macheras and published by Springer Science & Business Media. This book was released on 2006-04-26 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a novel modeling approach to biopharamceutics, pharmacokinetics and pharmacodynamic phenomena. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. Throughout, many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.
Download or read book Physiologically Based Pharmacokinetic PBPK Modeling and Simulations written by Sheila Annie Peters and published by John Wiley & Sons. This book was released on 2012-02-17 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only book dedicated to physiologically-based pharmacokinetic modeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has become increasingly widespread within the pharmaceutical industry over the last decade, but without one dedicated book that provides the information researchers need to learn these new techniques, its applications are severely limited. Describing the principles, methods, and applications of PBPK modeling as used in pharmaceutics, Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations fills this void. Connecting theory with practice, the book explores the incredible potential of PBPK modeling for improving drug discovery and development. Comprised of two parts, the book first provides a detailed and systematic treatment of the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics. The second part looks in greater detail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for a brief overview of the field as well as those who need more detail, the book includes a range of important learning aids. Featuring end-of-chapter keywords for easy reference a valuable asset for general or novice readers without a PBPK background along with an extensive bibliography for those looking for further information, Physiologically- Based Pharmacokinetic (PBPK) Modeling and Simulations is the essential single-volume text on one of the hottest topics in the pharmaceutical sciences today.
Download or read book Introduction to Population Pharmacokinetic Pharmacodynamic Analysis with Nonlinear Mixed Effects Models written by Joel S. Owen and published by John Wiley & Sons. This book was released on 2014-07-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a user-friendly, hands-on introduction to the Nonlinear Mixed Effects Modeling (NONMEM) system, the most powerful tool for pharmacokinetic / pharmacodynamic analysis. • Introduces requisite background to using Nonlinear Mixed Effects Modeling (NONMEM), covering data requirements, model building and evaluation, and quality control aspects • Provides examples of nonlinear modeling concepts and estimation basics with discussion on the model building process and applications of empirical Bayesian estimates in the drug development environment • Includes detailed chapters on data set structure, developing control streams for modeling and simulation, model applications, interpretation of NONMEM output and results, and quality control • Has datasets, programming code, and practice exercises with solutions, available on a supplementary website
Download or read book Basic Pharmacokinetics and Pharmacodynamics written by Sara E. Rosenbaum and published by John Wiley & Sons. This book was released on 2016-11-22 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated with new chapters and topics, this book provides a comprehensive description of all essential topics in contemporary pharmacokinetics and pharmacodynamics. It also features interactive computer simulations for students to experiment and observe PK/PD models in action. • Presents the essentials of pharmacokinetics and pharmacodynamics in a clear and progressive manner • Helps students better appreciate important concepts and gain a greater understanding of the mechanism of action of drugs by reinforcing practical applications in both the book and the computer modules • Features interactive computer simulations, available online through a companion website at: https://web.uri.edu/pharmacy/research/rosenbaum/sims/ • Adds new chapters on physiologically based pharmacokinetic models, predicting drug-drug interactions, and pharmacogenetics while also strengthening original chapters to better prepare students for more advanced applications • Reviews of the 1st edition: “This is an ideal textbook for those starting out … and also for use as a reference book …." (International Society for the Study of Xenobiotics) and “I could recommend Rosenbaum’s book for pharmacology students because it is written from a perspective of drug action . . . Overall, this is a well-written introduction to PK/PD …. “ (British Toxicology Society Newsletter)
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.
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.
Download or read book Innovations for Next Generation Antibody Drug Conjugates written by Marc Damelin and published by Springer. This book was released on 2018-05-29 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibody-drug conjugates (ADCs) stand at the verge of a transformation. Scores of clinical programs have yielded only a few regulatory approvals, but a wave of technological innovation now empowers us to overcome past technical challenges. This volume focuses on the next generation of ADCs and the innovations that will enable them. The book inspires the future by integrating the field’s history with novel strategies and cutting-edge technologies. While the book primarily addresses ADCs for solid tumors, the last chapter explores the emerging interest in using ADCs to treat other diseases. The therapeutic rationale of ADCs is strong: to direct small molecules to the desired site of action (and away from normal tissues) by conjugation to antibodies or other targeting moieties. However, the combination of small and large molecules imposes deep complexity to lead optimization, pharmacokinetics, toxicology, analytics and manufacturing. The field has made significant advances in all of these areas by improving target selection, ADC design, manufacturing methods and clinical strategies. These innovations will inspire and educate scientists who are designing next-generation ADCs with the potential to transform the lives of patients.
Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer. This book was released on 2016-10-06 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.
Download or read book Monte Carlo Simulation for the Pharmaceutical Industry written by Mark Chang and published by CRC Press. This book was released on 2010-09-29 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and metho
Download or read book Drug Delivery Approaches written by Bret Berner and published by John Wiley & Sons. This book was released on 2021-08-31 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.
Download or read book Physiologically Based Population Pharmacokinetic pharmacodynamic Modeling and Simulation Approaches to Support Waivers of in Vivo Clinical Pharmacology Studies written by Ioannis Loisios-Konstantinidis and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmacokinetics and Pharmacodynamics of Biotech Drugs written by Bernd Meibohm and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.
