Pharmaceutical Statistics Using SAS

11.5. Dose-Finding Procedures

As was indicated in Section 11.1, once a positive dose-response has been established, clinical researchers are interested in determining the optimal dose range for their experimental drug known as the therapeutic window. As an example, the usual adult dosage range for prescription ibuprofen is 200 to 800 mg three or four times per day, not to exceed 3200 mg total daily. In other words, ibuprofen's therapeutic window extends from 600 mg to 3200 mg per day. The therapeutic window is more conservative for over-the-counter (OTC) versions. The usual adult dosage range for OTC ibuprofen is 200 to 400 mg every four to six hours, not to exceed 1200 mg total daily.

The therapeutic window is defined by the minimum effective ...