Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors’ many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of the key ideas, using linear models as examples. Applying the linearization in the parameter space, it then covers nonlinear models and locally optimal designs as well as minimax, optimal on average, and Bayesian designs. The authors also discuss adaptive designs, focusing on procedures with non-informative stopping. The common goals of experimental design—such as reducing costs, supporting efficient decision making, and gaining maximum information under various constraints—are often the same across diverse applied areas. Ethical and regulatory aspects play a much more prominent role in biological, medical, and pharmaceutical research. The authors address all of these issues through many examples in the book.
Here, the authors explain the basic ideas so as to generate interest in modern problems of experimental design. The topics discussed include designs for inference based on nonlinear models, designs for models with random parameters and stochastic processes, designs for model discrimination and incorrectly specified (contaminated) models, as well as examples of designs in functional spaces. Since the authors avoid technical details, the book assumes only a moderate background in calculus, matrix algebra, and statistics. However, at many places, hints are given as to how readers may enhance and adopt the basic ideas for advanced problems or applications. This allows the book to be used for courses at different levels, as well as serving as a useful reference for graduate students and researchers in statistics and engineering.
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