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 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 2014-06-19 with total page 368 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 Case Studies in Bayesian Statistics written by Constantine Gatsonis and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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 Paediatric Clinical Pharmacology written by Evelyne Jacqz-Aigrain and published by CRC Press. This book was released on 2021-02-25 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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 Drug Discovery and Evaluation Safety and Pharmacokinetic Assays written by H. Gerhard Vogel and published by Springer. This book was released on 2013-02-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: -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

Download or read book Population Pharmacokinetics written by Ekaterina Gibiansky and published by . This book was released on 1999 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The work is devoted to the application and further development of modern statistical methods to study pharmacokinetics of drugs. Specifically, it deals with applications and development of repeated measures analysis, so called 'population approach' methods, in the field of pharmacokinetics. hi the first part of the thesis, a new, model-free approach is developed and tested. It introduces a model-free measure of patient's exposure to drugs, and then investigates the relationships between the exposure level and covariates using various statistical techniques. Classification tree models (CART) and regression analysis are used to study various subpopulations of interest. It is shown, via simulations, that the model-free method is capable to identify predictors of exposure in a wide range of variability in the data. The non-linear mixed effect modelling is used to confirm the results of the model-free investigation. Model-free approach is successfully applied to several drugs. Non-linear Mixed Effects population models developed for the same data agree with its results. Limits of the new method are also identified. Specifically, it does not allow the estimation of the variability: either the within-subject (intra-individual) variability in response, or between-subject (inter-individual) variability of the pharmacokinetic parameters in the population. The second part of the thesis is devoted to applications of the Non-linear Mixed Effect methodology to population pharmacokinetics and dose-response analysis. Population pharmacokinetic and dose-response models of several drugs are developed. Pharmacokinetic models allow for complete characterisation of the drug's pharmacokinetics and its relationships to safety and efficacy. The developed models are used to explore the relationships between the exposure (individual Bayes estimates) and demographic predictors of exposure, and safety and efficacy of the drug. Finally, the developed models are used in simulations to guide the design of new studies.

Download or read book Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African American Populations written by Institute of Medicine and published by National Academies Press. This book was released on 1997-08-25 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reports in the popular press about the increasing longevity of Americans and the aging of the baby boom generation are constant reminders that the American population is becoming older. Consequently, an issue of growing medical, health policy, and social concern is the appropriate and rational use of medications by the elderly. Although becoming older does not necessarily correlate with increasing illness, aging is associated with anatomical and physiological changes that affect how medications are metabolized by the body. Furthermore, aging is often related to an increased frequency of chronic illness (often combined with multiple health problems) and an increased use of medications. Thus, a better understanding of the absorption, distribution, metabolism, and excretion of drugs; of the physiologic responses to those medications; as well as of the interactions among multiple medications is crucial for improving the health of older people.

Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Comparative Pharmacokinetics written by Jim E. Riviere and published by John Wiley & Sons. This book was released on 2011-01-14 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in a revised edition, Comparative Pharmacokinetics: Principles, Techniques, and Applications presents the principles and techniques of comparative and veterinary pharmacokinetics in a detailed yet practical manner. Developed as a tool for ensuring that pharmacokinetics studies are properly designed and correctly interpreted, the book provides complete coverage of the conceptual basis of pharmacokinetics as used for quantifying biological processes from the perspectives of physiology and medicine. New chapters have been added on quantitative structure permeability relationships and bioequivalence, and a number of existing chapters have been significantly revised and expanded to provide a current resource for veterinary and comparative pharmacokinetics.

Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2005-12-05 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. The volumes fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Download or read book Pharmacokinetics in Drug Discovery and Development written by Ronald D. Schoenwald and published by CRC Press. This book was released on 2002-03-06 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existi

Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2005-12-05 with total page 648 pages. Available in PDF, EPUB and Kindle. Book excerpt: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. They fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Download or read book Handbook of Pharmacokinetics and Toxicokinetics written by Mehdi Boroujerdi and published by CRC Press. This book was released on 2023-08-22 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fully revised and expanded volume is an effort to blend the common approaches to pharmacokinetics and toxicokinetics. It integrates the principles held in common by both fields through a logical and systematic approach, which includes mathematical descriptions of physical and physiological processes employed in the approaches to pharmacokinetics and toxicokinetics modeling. It emphasizes general principles and concepts and related, isolated applications and case study observations. The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research, scientific or regulatory decisions, or for offering advanced courses/workshops and seminars. Features: Comprehensive handbook on principles and applications of PK/TK appealing to a diverse audience including scientists and students An excellent text fully revised and fully updated for anyone interested in the theoretical and practical pharmacokinetics The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research Incorporates research relevant to SDGs and of interest to industrial and regulatory environmental scientists involved in chemical contamination research and regulatory decision making related to soil, water, and ocean Includes sections on applications and case studies

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.

Download or read book Pharmacokinetics and Toxicokinetics written by Mehdi Boroujerdi and published by CRC Press. This book was released on 2015-02-24 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacokinetics and Toxicokinetics provides an overview of pharmacokinetics and toxicokinetics in a comprehensible, interrelated, and applied manner. It integrates the principles held in common by both fields through a logical and systematic approach. The book presents mathematical descriptions of physiological processes employed in different appr