Regulatory affairs in biotechnology: optimal statistical designs for biomedical experiments.

One of the major issues in all applications of biotechnology is how to regulate the process through which new technological information is produced. The end products of biotechnological applications are diverse (e.g., better drugs, better interventions, better fertilizers). Such applications should be properly regulated to obtain valid scientific findings in the most efficient way possible. Some statistically optimal designs are more popularly employed than others as regulatory tools in medical, pharmaceutical and clinical trials. The statistical and practical properties (strengths and weaknesses) are presented to better appreciate their optimality. Recent developments on some related issues are also reviewed.