By Lewis
Describes the statistical making plans and layout of pharmaceutical experiments, protecting all levels within the improvement process—including preformulation, formula, approach examine and optimization, scale-up, and powerful strategy and formula improvement. exhibits easy methods to conquer pharmaceutical, technological, and monetary constraints on test layout.
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E. Coleman, D. C. Montgomery, B. H. Gunter, G. J. Hahn, P. D. Haaland, M. A. O'Connell, R. V. Leon, A. C. -L. Trui, A systematic approach to planning for a designed experiment, Discussion, Response, Technometrics, 35, 1-27 (1993). 2. W. F. Stansbury, Development of experimental designs for organic synthetic reactions, Chemom. Intell. Lab. Syst. 36, 199-206 (1997), 3. D. C. Montgomery, Design and Analysis of Experiments, 2nd edition, J. Wiley, N. , 1984. 4. J. C. Miller and J. N. Miller, Statistics for Analytical Chemistry, Ellis Horwood, Chichester, U.
This present work, which attempts a practical introduction to the range of approaches useful in pharmaceutical development, does not attempt to replace these in any way. Two works in particular are essential reading Statistics for Experimenters, by Box, Hunter, and Hunter (6), and Cornell's book, Experiments with Mixtures (8). Other valuable texts are given here (9, 10, 11) or referenced later in the book. D. Choosing Computer Software The experimenter wishing to use statistical design will quickly find he needs to buy a program for multi-linear regression.
The problem of more than 2 levels of a qualitative variable will be treated in the following section. The upper and lower limits of the quantitative, continuous variables, Xt, X2, X3 and X4 were close to one another so it was considered probable that a linear model can be used to realistically describe the system. For the same reason we expected interactions between these variables to be negligible, that is, the effect of changing any one variable (such as temperature) will not be dependent on the current value of another variable (such as the stirrer speed).