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- W70954471 abstract "Pharmacokinetic/pharmacodynamic (PK/PD) modeling of ordered categorical scales may provide insight into drug response by utilizing relatively small samples of subjects. Two lorazepam adverse events (AEs), sleepiness and dizziness, were modeled to identify differences in PD parameters and differences compared to relative incidence rates in the drug label (15.7% and 6.9%, respectively). Healthy volunteers (n=20) received single oral doses of 2 mg lorazepam or placebo in a randomized, double-blind, cross-over fashion. A 7 point categorical scale measuring the intensity of AEs was serially administered over 24 hr. PK samples were obtained over 72 hr. The Maximum Score (MaxS), and Area Under the Effect Curve (AUEC) were determined by noncompartmental methods and compared using a paired t-test. Individual scores were modeled using a logistic function. AUEC and MaxS for sleepiness were significantly higher than dizziness (20.35 vs. 9.76, p<0.01) and (2.35 vs.1.45, P<0.01). Model slope estimates were similar for sleepiness and dizziness (0.21 vs. 0.19 logits*ml/ng), but baseline logits were significantly higher for sleepiness (-2.81 vs. -4.34 logits). Therefore, the higher intensity of sleepiness may be directly related to baseline (no drug present) while the increase in intensity due to drug was relatively similar for both AEs." @default.
- W70954471 created "2016-06-24" @default.
- W70954471 creator A5077126049 @default.
- W70954471 date "2008-01-01" @default.
- W70954471 modified "2023-09-23" @default.
- W70954471 title "The pharmacokinetics and pharmacodynamics of CNS-acting agents" @default.
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- W70954471 hasPublicationYear "2008" @default.
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