Pharmacometrics

Autor: Ene I. Ette
Publisher: John Wiley & Sons
ISBN: 1118679512
File Size: 35,67 MB
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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.

Pharmacometrics

Autor: Ene I. Ette
Publisher: Wiley
ISBN: 9781118862896
File Size: 70,59 MB
Format: PDF, Mobi
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This book 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. With key updates, the new edition includes new ideas and concepts while at the same time containing ideas that provide a window into the ever-expanding frontier of pharmacometrics and its continued impact on drug development, regulation, and evaluation. In particular, model-based meta-analysis and modeling unusual data is expanded as these approaches have become much more widely used and warrant detailed treatment. A companion website contains pattern for writing codes and appendices featuring pointers to codes.

Pharmacokinetic And Pharmacodynamic Data Analysis Concepts And Applications Third Edition

Autor: Johan Gabrielsson
Publisher: CRC Press
ISBN: 9789186274924
File Size: 71,63 MB
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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.

Pharmacokinetic Pharmacodynamic Modeling And Simulation

Autor: Peter L. Bonate
Publisher: Springer Science & Business Media
ISBN: 9781441994851
File Size: 23,61 MB
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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.

Systems Pharmacology And Pharmacodynamics

Autor: Donald E. Mager
Publisher: Springer
ISBN: 3319445340
File Size: 64,37 MB
Format: PDF
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While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.

Basic Pharmacokinetics And Pharmacodynamics

Autor: Sara E. Rosenbaum
Publisher: John Wiley & Sons
ISBN: 111819778X
File Size: 48,92 MB
Format: PDF, ePub
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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.

Applied Pharmacometrics

Autor: Stephan Schmidt
Publisher: Springer
ISBN: 1493913042
File Size: 14,21 MB
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This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer’s disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.

Textbook Of Receptor Pharmacology Second Edition

Autor: John C. Foreman
Publisher: CRC Press
ISBN: 9781420041071
File Size: 22,27 MB
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The bestselling first edition of Textbook of Receptor Pharmacology originated from a renowned course in receptor pharmacology taught at the University College of London for the past three decades. Its innovative format united four major approaches to the study of receptors: molecular biology, quantitative functional studies of agonists and antagonists, ligand binding, and signal transduction systems. The second edition builds on this foundation. This edition streamlines the material and focuses on cell membrane receptors along with their immediate signal transducers. The section on the molecular structure of receptors reflects the advances in this area. This edition also includes two restructured new chapters, one on G-proteins and one on tyrosine kinases, as signal transductors. Several chapters also contain problems for students to solve as well as worked-out solutions. The book contains over one hundred useful diagrams and tables to aid illustration of concepts and a helpful appendix explaining the simple mathematics used in the text. A time-saving resource and comprehensive textbook, Textbook of Receptor Pharmacology, Second Edition provides in-depth, up-to-date coverage of this still rapidly expanding research area that is both fundamental to the science of pharmacology and on the cutting edge of new drug development.

Benefit Risk Assessment Methods In Medical Product Development

Autor: Qi Jiang
Publisher: CRC Press
ISBN: 1315355019
File Size: 64,84 MB
Format: PDF, ePub
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Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.