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Pharmaceutical Experimental Design : Drugs and the Pharmaceutical Sciences - Gareth A. Lewis

Pharmaceutical Experimental Design

By: Gareth A. Lewis, Didier Mathieu, Roger Phan-Tan-Luu

Hardcover | 1 January 1999 | Edition Number 1

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This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design ? offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books ? reviews screening designs for qualitative factors at different levels ? presents designs for predictive models and their use in optimization ? highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability ? discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer ? details nonstandard designs and mixtures ? analyzes factorial, D-optimal design, and offline quality assurance techniques ? reveals how one experimental design evolves from another ? and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.
Industry Reviews
"This is definitely a book on experimental design in the classical style, as Box et al. (1978) indicated. The book has plenty of illustrations. It also has very much use of verbal text compared to most design-of-experiments books. "- Technometrics Written in a lucid style, the book covers a myriad aspects of DOE [design of experiments] and optimization....Most of the statistical designs popular in pharmaceutical practice have been discussed quite elaborately listing their relative merits and demerits with distinct emphasis to factorial design....The remarkable highlight of the book is that is covers all the important steps in formulation development ....a diversity of graphic outcomes of DOE optimization has been immaculately presented circum-navigating the mathematicostatical complexities.... ...an excellent addition to library shelves in industry and academia - The Eastern Pharmacist, 2000

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