Applied Pharmacometrics

Applied Pharmacometrics PDF Author: Stephan Schmidt
Publisher: Springer
ISBN: 1493913042
Category : Medical
Languages : en
Pages : 570

Get Book Here

Book Description
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.

Applied Pharmacometrics

Applied Pharmacometrics PDF Author: Stephan Schmidt
Publisher: Springer
ISBN: 1493913042
Category : Medical
Languages : en
Pages : 570

Get Book Here

Book Description
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.

Pharmacometrics

Pharmacometrics PDF Author: Ene I. Ette
Publisher: John Wiley & Sons
ISBN: 1118679512
Category : Medical
Languages : en
Pages : 1236

Get Book Here

Book Description
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.

Pharmacokinetic-Pharmacodynamic Modeling and Simulation

Pharmacokinetic-Pharmacodynamic Modeling and Simulation PDF Author: Peter L. Bonate
Publisher: Springer Science & Business Media
ISBN: 1441994858
Category : Medical
Languages : en
Pages : 634

Get Book Here

Book Description
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.

Clinical Trial Simulations

Clinical Trial Simulations PDF Author: Holly H. C. Kimko
Publisher: Springer Science & Business Media
ISBN: 1441974156
Category : Medical
Languages : en
Pages : 540

Get Book Here

Book Description
This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

Translational Biomedical Informatics

Translational Biomedical Informatics PDF Author: Bairong Shen
Publisher: Springer
ISBN: 9811015031
Category : Science
Languages : en
Pages : 331

Get Book Here

Book Description
This book introduces readers to essential methods and applications in translational biomedical informatics, which include biomedical big data, cloud computing and algorithms for understanding omics data, imaging data, electronic health records and public health data. The storage, retrieval, mining and knowledge discovery of biomedical big data will be among the key challenges for future translational research. The paradigm for precision medicine and healthcare needs to integratively analyze not only the data at the same level – e.g. different omics data at the molecular level – but also data from different levels – the molecular, cellular, tissue, clinical and public health level. This book discusses the following major aspects: the structure of cross-level data; clinical patient information and its shareability; and standardization and privacy. It offers a valuable guide for all biologists, biomedical informaticians and clinicians with an interest in Precision Medicine Informatics.

Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics

Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics PDF Author: Alexander A. Vinks
Publisher: Springer Science & Business Media
ISBN: 0387756132
Category : Medical
Languages : en
Pages : 467

Get Book Here

Book Description
Over the past decade, significant progress has been made in the theory and applications of pharmacodynamics of antimicrobial agents. On the basis of pharmacokinetic-pharmacodynamic modeling concepts it has become possible to describe and predict the time course of antimicrobial effects under normal and pathophysiological conditions. The study of pharmacokinetic-pharmacodynamic relationships can be of considerable value in understanding drug action, defining optimal dosing regimens, and in making predictions under new or changing pre-clinical and clinical circumstances. Not surprisingly, pharmacokinetic-pharmacodynamic modeling concepts are increasingly applied in both basic and clinical research as well as in drug development. The book will be designed as a reference on the application of pharmacokinetic-pharmacodynamic principles for the optimization of antimicrobial therapy, namely pharmacotherapy, and infectious diseases. The reader will be introduced to various aspects of the fundamentals of antimicrobial pharmacodynamics, the integration of pharmacokinetics with pharmacodynamics for all major classes of antibiotics, and the translation of in vitro and animal model data to basic research and clinical situations in humans.

Respiratory Delivery of Biologics, Nucleic Acids, and Vaccines

Respiratory Delivery of Biologics, Nucleic Acids, and Vaccines PDF Author: Jenny Lam
Publisher: Springer Nature
ISBN: 3031475674
Category : Medical
Languages : en
Pages : 224

Get Book Here

Book Description
Therapeutic macromolecules and biologics have gained increasing importance in the last decade. Pulmonary and intranasal delivery of these therapeutic modalities, which have poor oral bioavailability, could constitute an attractive, non-invasive alternative to parenteral delivery. They can be considered for either topical use for treating diseases affecting the airways or for systemic use for treating a variety of other diseases. Therefore, this book is a readable, thoughtful, and useful guide on the latest research developments and the best options that people involved with pulmonary and intranasal route of administration and biologically active agents can bring to their practices. Furthermore, it explores the underlying scientific rationale for the strategies applied to overcome drug delivery challenges and provides insights to inspire further research in this growing area.

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications PDF Author: Hartmut Derendorf
Publisher: Lippincott Williams & Wilkins
ISBN: 1496385896
Category : Medical
Languages : en
Pages : 1334

Get Book Here

Book Description
Updated with the latest clinical advances, Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics, Fifth Edition , explains the relationship between drug administration and drug response, taking a conceptual approach that emphasizes clinical application rather than science and mathematics. Bringing a real-life perspective to the topic, the book simplifies concepts and gives readers the knowledge they need to better evaluate drug applications.

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

Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition PDF Author: Johan Gabrielsson
Publisher: CRC Press
ISBN: 9789186274924
Category : Medical
Languages : en
Pages : 926

Get Book Here

Book Description
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.

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Pharmaceutical Inhalation Aerosol Technology, Third Edition PDF Author: Anthony J. Hickey
Publisher: CRC Press
ISBN: 042962171X
Category : Medical
Languages : en
Pages : 747

Get Book Here

Book Description
This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors