From Discovery through Development
Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications
by Johan Gabrielsson and Daniel Weiner
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Still Doing PK/PD Modeling and Analysis the Hard Way?
Although most scientists involved with pharmacokinetic and pharmacodynamic data analysis use computers to produce PK/PD models, there has, up until now, been very little literature available that explains, in simple terms, how to fit models and interpret output data.
This new and expanded edition of the book, Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, by Johan L. Gabrielsson Ph.D., Uppsala, Sweden and Daniel L. Weiner, Ph.D., Research Triangle Park, USA, differs substantially from the first edition in that pharmacokinetic and pharmacodynamic theory as well as modeling concepts are expanded. Detailed sections on NCA, non-linear kinetics (capacity, time, flow and binding), turnover concepts, pulsative functions, push-and-pull and precursor models, binding and displacement models, toxicokinetic models and determination of initial parameter estimates for complex models are included. There is also a new chapter on Experimental Design.
Part one of the text is a basic introduction to pharmacokinetic and pharmacodynamic modeling principles and can be understood by scientists with very little formal training in this area. Complex mathematics are minimized. Extensive graphical presentations accompany the theory. This enables the scientist to conceptualize the underlying principles, such as clearance, potency, tolerance weighting and search algorithms. Issues on program validation are also discussed. The addition of new case studies makes each chapter on basic concepts more useful for teaching and professional analyses.
Part two is aimed to illustrate the application of concepts to specific modeling situations commonly encountered at the drug industry and in research labs. Several new exciting data sets on tolerance-rebound, dose-response-time models, bacterial growth model, turnover, non-linear kinetics, oscillating input functions and toxicokinetics are also solved and discussed in this section. The book bridges the gap between standard texts in pharmacokinetics, pharmacology and numerical analysis and provides unique insight into the field of pharmacometrics in an easy to understand manner. More than 100 data sets and practical solutions are included.
This revised and expanded edition includes a CD with all exercises and WinNonlin® model/command files. The command files are intended both as a complement to the book and as a framework for the user's own modeling problems, thereby saving time when carrying out data analysis. The files may also be used for program validation. CDs are not copy protected and are available for use with any Edition of WinNonlin.
Book and CD $ 175
ISBN 91 9765 100 1
ISBN-13 978 91 9765 100 4