Experimental design, pharmaceutical

Bonate, P.L. Coverage and precision of parametric and non-parametric confidence intervals for area under the curve in a toxicokinetic experimental design. Pharmaceutical Research 1998 15 405 -10. 

Armstrong, N. A. James, K. C. Pharmaceutical Experimental Design and Interpretation. Taylor and Francis London, 1996 as cited in Gonzalez, A. G. Anal. Chim. Acta 1998, 360, 227—241. 

Togkalidou, T., Braatz, R.D., Johnson, B.K., Davidson, O. and Andrews, A., 2001. Experimental design and inferential modelling in pharmaceutical crystallization. American Institution of Chemical Engineers Journal, 47(1), 160-168. 

Pharmaceutical Experimental Design, Gareth A. Lewis, Didier Mathieu, and Roger Phan-Tan-Luu... 

In addition to rodent studies, regulatory guidelines for pharmaceuticals require that repeated dose safety studies of up to nine months (in the United States, six months elsewhere) in duration be conducted in a nonrodent species. The most commonly used nonrodent species is the dog, followed by the monkey and pig. Another nonrodent model used to a limited extent in systemic safety evaluation is the ferret. The major objectives of this chapter are (1) to discuss differences in rodent and nonrodent experimental design, (2) to examine the feasibility of using the dog, monkey, pig, and ferret in safety assessment testing, and (3) to identify the advantages and limitations associated with each species. 

Ragonese, R., Macka, M., Hughes, J., and Petocz, P. (2002). The use of the Box-Behnken experimental design in the optimisation and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation. J. Pharm. Biomed. Anal. 27, 995-1007. 

Experimental design A group of 68 workers occupationally exposed to chloroform for 1-4 years in a pharmaceutical plant were examined. Doses of inhaled chloroform ranged from 2 to 205 ppm over a 1-4-year-period. Air concentrations of chloroform ranged from 0.01 mg/L to 1 mg/L. Other solvents were reported in the air in trace amounts. 

Lewis, GA. and Chariot, M. Non classical experimental designs in pharmaceutical formulBtiogs,... 

Only applied originally in the pharmaceutical industry, automated synthetic methods have spread quickly into the research for new agrochemicals, other speciality chemicals, catalysts and new materials. It is also being used increasingly in process development laboratories coupled with statistical experimental design. 

Most chemists, whether biochemists, organic, analytical, pharmaceutical or clinical chemists, and many pharmacists and biologists need to perform chemical analysis. Consequently, they are not only confronted with carrying out the actual analysis, but also with problems such as method selection, experimental design, optimization, calibration, data acquisition and handling, and statistics in order to obtain maximum relevant chemical information. In other words they are confronted with chemometrics. 

Armstrong James UNDERSTANDING EXPERIMENTAL DESIGN AND INTERPRETATION IN PHARMACEUTICS... 

---