کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486052 | 1114373 | 2010 | 14 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Pharmacodynamic Differentiation of Lorazepam Sleepiness and Dizziness Using an Ordered Categorical Measure
دانلود مقاله + سفارش ترجمه
دانلود مقاله ISI انگلیسی
رایگان برای ایرانیان
کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Pharmacodynamic Differentiation of Lorazepam Sleepiness and Dizziness Using an Ordered Categorical Measure Pharmacodynamic Differentiation of Lorazepam Sleepiness and Dizziness Using an Ordered Categorical Measure](/preview/png/2486052.png)
چکیده انگلیسی
Categorical measures of lorazepam sleepiness and dizziness were modeled to identify differences in pharmacodynamic (PD) parameters between these adverse events (AEs). Differences in data-derived PD parameters were compared with 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 seven-point categorical scale measuring the intensity of AEs was serially administered over 24 h. 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 implemented in NONMEM. 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 logits à mL/ng vs. 0.19 logits à mL/ng), but baseline logits were significantly higher for sleepiness (â 2.81 vs. â 4.34 logits). Data-derived PD parameters were in concordance with label incidence rates. The higher intensity of sleepiness may be directly related to baseline (no drug present) while the increase in intensity as a result of drug was relatively similar for both AEs.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 8, August 2010, Pages 3628-3641
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 8, August 2010, Pages 3628-3641
نویسندگان
Mohamed A. Kamal, David E. Smith, Jack Cook, Douglas Feltner, Allen Moton, Daniele Ouellet,