A Methodology Using Subjective Responses to Discriminate Between Pharmaceutical Preparations

¹ Research and Development Division, Smith Kline & French Laboratories, Philadelphia, Penn.

A double-blind crossover study was conducted to compare placebo, a plain form of dextroamphetamine, and a sustained-release form of dextroamphetamine in 30 volunteers. Measurements included blood pressure, pulse, and an adjective checklist. Data were recorded before drug administration and 3, 5, 7, and 9 hours after administering the single-dose regimens.

Principal component analyses of the adjective checklist developed several factors for further analyses. Three factors reported were named "active,""drowsy," and "stimulation." The first two factors were found in the predrug, placebo, and active drug data. The "stimulation" factor was found only in the dextroamphetamine data.

All criteria show a statistically significant difference between average responses following the placebo and averages for the active regimens.

Systolic blood pressure and average scores for the three factors all show statistically significant drug form-by-time interactions. Tables of averages show an early maximum response for the plain form compared with a delayed and lower maximum response for the sustained-release form.

Scores for the "stimulation" factor also show a statistically significant difference between the overall results of the two active regimens. Consistently higher averages in factor scores are reported for the plain form.

Several statistically desirable features of the methodology and experimental design are discussed.

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