Synthelabo Recherche, Chilly Mazarin, France. Describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process, including preformulation, formulation, process study, and optimization. Halftone graphs and tables. Modified-outline format. For researchers.
Preface
iii
1. Overview The scope of experimental design
1
(22)
2. Screening Designs for identifying active factors
23
(56)
3. Factor Influence Studies Applications of full and fractional factorial designs at 2 levels
79
(72)
4. Statistical and Mathematical Tools Introduction to multi-linear regression and analysis of variance
151
(34)
5. Response Surface Methodology Predicting responses within the experimental region
185
(62)
6. Optimization Pharmaceutical process optimization and validation
247
(48)
7. Variability and Quality Analysing and minimizing variation
295
(32)
8. Exchange Algorithms Methods for non-standard designs
327
(24)
9. Mixtures Introduction to statistical experimental design for formulation
351
(62)
10. Mixtures in a Constrained Region of Interest Screening, defining the domain, and optimizing formulations
413
(42)
Appendix I. A Summary of Matrix Algebra
455
(5)
Appendix II. Experimental Designs and Models for Screening
460
(13)
Appendix III. Designs for Response Surface Modelling
473
(8)
Appendix IV. Choice of Computer Software
481
(9)
Appendix V. Symbols
490
(3)
Index
493
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