Ten patients with well-controlled seizures receiving chronic phenytoin (PHT) monotherapy for seizure prophylaxis completed a randomized double-blind crossover study comparing brand-name and generic PHT. Each patient received the same dose of each preparation for 3 months during which trough PHT concentrations and adverse effects were monitored. The average predose steady-state total PHT concentration was 11.9 +/- 4.9 micrograms/ml during brand-name therapy and 14.2 +/- 8.2 micrograms/ml during generic therapy. The average predose steady-state free PHT concentrations were 0.93 +/- 0.47 micrograms/ml (brand name) and 1.14 +/- 0.64 micrograms/ml (generic), respectively (p less than 0.005). The potency (capsule content) values for the lots used in the study were 99.2% for the brand-name and 104.6% for generic. Because of the nonlinear Michaelis-Menten kinetics of PHT, a 5.4% difference in potency could account for the observed differences in plasma concentrations. When compared with brand-name PHT therapy, the generic drug was associated with an increase in serum concentration. This increase was consistent with the reported difference in capsule content between the generic and brand-name lots used in this study.
The Diagnostic Rating Scale (DRS) was completed by the parents and teachers of 82 children referred for clinical evaluations, 73 referred children seen twice, and 218 non-referred children from the community. The DRS, which uses a categorical rather than a dimensional rating approach, was 70% to 90% sensitive to diagnoses of Attention Deficit/Hyperactivity Disorder (ADHD) made by blind clinical teams. In research and clinical applications, the DRS could improve screening efficiency, especially in situations where it would be desirable to exclude all children who might have ADHD or identify all children with Hyperactive-Impulsive symptoms. Because of its objectivity and consistency with the Diagnostic and Statistical Manual (DSM)-IV criteria, the DRS could facilitate comparison of participant samples across studies.
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