Pharmaceutical Statistics Using SAS

14.7. Selection of an Optimal Dose

One of the most crucial decisions in the development of a new drug is which dose to use. The situation varies between different indications. Sometimes the dose can be titrated for each patient, sometimes the dose is individualised based on gender, body weight, genetic constitution and other factors. Often one looks for a one-dose-fits-all. The optimal dose is a compromise between beneficial effects and undesired side effects. In general, both effects and, especially, side effects, may be multi-dimensional. As a further complication, which side effects are important may not be clear until after the Phase III programme or even after marketing of the drug. We choose to treat only the simple situation with a one-dimensional ...