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.

Contents

1. Overview
2. Screening
3. Factor Influence Studies
4. Statistical and Mathematical Tools
5. Response Surface Methodology
6. Optimization
7. Variability and Quality
8. Exchange Algorithms
9. Mixtures
10. Mixtures in a Constrained Region of Interest

Appendix I. A Summary of Matrix Algebra
Appendix II. Experimental Designs and Models for Screening
Appendix III. Designs for Response Surface Modeling
Appendix IV. Choice of Computer Software
Appendix V. Symbols

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