Author: Joel S. Owen
Publisher: John Wiley & Sons
ISBN: 9780470582299
Category : Medical
Languages : en
Pages : 0
Book Description
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
Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models
Author: Joel S. Owen
Publisher: John Wiley & Sons
ISBN: 9780470582299
Category : Medical
Languages : en
Pages : 0
Book Description
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
Publisher: John Wiley & Sons
ISBN: 9780470582299
Category : Medical
Languages : en
Pages : 0
Book Description
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
Case Studies in Bayesian Statistics
Author: Constantine Gatsonis
Publisher: Springer Science & Business Media
ISBN: 9780387986401
Category : Mathematics
Languages : en
Pages : 454
Book Description
The 4th Workshop on Case Studies in Bayesian Statistics was held at the Car negie Mellon University campus on September 27-28, 1997. As in the past, the workshop featured both invited and contributed case studies. The former were presented and discussed in detail while the latter were presented in poster format. This volume contains the four invited case studies with the accompanying discus sion as well as nine contributed papers selected by a refereeing process. While most of the case studies in the volume come from biomedical research the reader will also find studies in environmental science and marketing research. INVITED PAPERS In Modeling Customer Survey Data, Linda A. Clark, William S. Cleveland, Lorraine Denby, and Chuanhai LiD use hierarchical modeling with time series components in for customer value analysis (CVA) data from Lucent Technologies. The data were derived from surveys of customers of the company and its competi tors, designed to assess relative performance on a spectrum of issues including product and service quality and pricing. The model provides a full description of the CVA data, with random location and scale effects for survey respondents and longitudinal company effects for each attribute. In addition to assessing the performance of specific companies, the model allows the empirical exploration of the conceptual basis of consumer value analysis. The authors place special em phasis on graphical displays for this complex, multivariate set of data and include a wealth of such plots in the paper.
Publisher: Springer Science & Business Media
ISBN: 9780387986401
Category : Mathematics
Languages : en
Pages : 454
Book Description
The 4th Workshop on Case Studies in Bayesian Statistics was held at the Car negie Mellon University campus on September 27-28, 1997. As in the past, the workshop featured both invited and contributed case studies. The former were presented and discussed in detail while the latter were presented in poster format. This volume contains the four invited case studies with the accompanying discus sion as well as nine contributed papers selected by a refereeing process. While most of the case studies in the volume come from biomedical research the reader will also find studies in environmental science and marketing research. INVITED PAPERS In Modeling Customer Survey Data, Linda A. Clark, William S. Cleveland, Lorraine Denby, and Chuanhai LiD use hierarchical modeling with time series components in for customer value analysis (CVA) data from Lucent Technologies. The data were derived from surveys of customers of the company and its competi tors, designed to assess relative performance on a spectrum of issues including product and service quality and pricing. The model provides a full description of the CVA data, with random location and scale effects for survey respondents and longitudinal company effects for each attribute. In addition to assessing the performance of specific companies, the model allows the empirical exploration of the conceptual basis of consumer value analysis. The authors place special em phasis on graphical displays for this complex, multivariate set of data and include a wealth of such plots in the paper.
Pharmacokinetic-Pharmacodynamic Modeling and Simulation
Author: Peter L. Bonate
Publisher: Springer Science & Business Media
ISBN: 1441994858
Category : Medical
Languages : en
Pages : 634
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.
Publisher: Springer Science & Business Media
ISBN: 1441994858
Category : Medical
Languages : en
Pages : 634
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.
Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Author: H. Gerhard Vogel
Publisher: Springer
ISBN: 9783642252396
Category : Medical
Languages : en
Pages : 0
Book Description
-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide
Publisher: Springer
ISBN: 9783642252396
Category : Medical
Languages : en
Pages : 0
Book Description
-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide
Pharmacometrics
Author: Ene I. Ette
Publisher: John Wiley & Sons
ISBN: 1118679512
Category : Medical
Languages : en
Pages : 1236
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.
Publisher: John Wiley & Sons
ISBN: 1118679512
Category : Medical
Languages : en
Pages : 1236
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.
Paediatric Clinical Pharmacology
Author: Evelyne Jacqz-Aigrain
Publisher: CRC Press
ISBN: 0849374448
Category : Medical
Languages : en
Pages : 830
Book Description
The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.
Publisher: CRC Press
ISBN: 0849374448
Category : Medical
Languages : en
Pages : 830
Book Description
The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.
Rational Therapeutics for Infants and Children
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309183642
Category : Medical
Languages : en
Pages : 135
Book Description
The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Publisher: National Academies Press
ISBN: 0309183642
Category : Medical
Languages : en
Pages : 135
Book Description
The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Applied Pharmacokinetics
Author: William E. Evans
Publisher: Applied Therapeutics, Incorporated
ISBN:
Category : Medical
Languages : en
Pages : 1236
Book Description
The Third Edition of Applied Pharmacokinetics remains the gold standard by which all other clinical pharmacokinetics texts are measured. Written by leading pharmacokinetics researchers and practitioners, this book is the most advanced kinetics reference available. All chapters have been extensively updated or completely rewritten for this edition, and six new chapters have been added on pharmacodynamics, pharmacogenetics, pharmacokinetic considerations in the obese, dietary influences on drug disposition, zidovudine, and corticosteroids. Each chapter is tightly focused on the most important concepts and issues. Chapters on specific drugs are organized in a consistent format for quick, easy information retrieval. Major subheadings include Clinical Pharmacokinetics, Pharmacodynamics, Clinical Application of Pharmacokinetic Data, Analytical Methods, and Prospectus.
Publisher: Applied Therapeutics, Incorporated
ISBN:
Category : Medical
Languages : en
Pages : 1236
Book Description
The Third Edition of Applied Pharmacokinetics remains the gold standard by which all other clinical pharmacokinetics texts are measured. Written by leading pharmacokinetics researchers and practitioners, this book is the most advanced kinetics reference available. All chapters have been extensively updated or completely rewritten for this edition, and six new chapters have been added on pharmacodynamics, pharmacogenetics, pharmacokinetic considerations in the obese, dietary influences on drug disposition, zidovudine, and corticosteroids. Each chapter is tightly focused on the most important concepts and issues. Chapters on specific drugs are organized in a consistent format for quick, easy information retrieval. Major subheadings include Clinical Pharmacokinetics, Pharmacodynamics, Clinical Application of Pharmacokinetic Data, Analytical Methods, and Prospectus.
Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models
Author: Joel S. Owen
Publisher: John Wiley & Sons
ISBN: 1118784618
Category : Medical
Languages : en
Pages : 368
Book Description
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
Publisher: John Wiley & Sons
ISBN: 1118784618
Category : Medical
Languages : en
Pages : 368
Book Description
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
Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition
Author: Johan Gabrielsson
Publisher: CRC Press
ISBN: 9789186274924
Category : Medical
Languages : en
Pages : 926
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.
Publisher: CRC Press
ISBN: 9789186274924
Category : Medical
Languages : en
Pages : 926
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.