Limited sampling models for the antiretroviral agent didanosine

Limited-Sampling Strategies for Anti-Infective Agents: Systematic Review

“…30 Five anti-infective agents were each studied in 2 separate trials, as described in Table 2. 25,28,[30][31][32]35,38,39,42,43 Classification according to level of evidence is important when there are discrepant results between studies for suggested sampling times to characterize pharmacokinetic parameters. As a general guideline, clinicians may choose to place more weight on results of studies classified as having a higher level of evidence.…”

“…The level I studies of didanosine and zidovudine also provided 1-sample limited-sampling strategies to predict a second pharmacokinetic parameter, maximum drug concentration (C max ). 25,26 Of the level I studies, the study of a validated limitedsampling strategy for nevirapine probably provided the most Table 1. Classification of studies of limited sampling strategies [5][6][7]9 Level of Evidence Description Level I (evidence obtained from at least one properly…”

“…Six studies of limited-sampling strategies were considered to present evidence of the highest quality (level I), describing strategies for didanosine, 25 zidovudine, 26 nevirapine, 27 ciprofloxacin, 28 efavirenz, 29 and nelfinavir 30 ( Table 2). Each study used prospectively collected data and proper validation procedures.…”

“…All 6 studies randomized pharmacokinetic data into index and validation groups, and 5 of the studies clearly randomized the pharmacokinetic data into independent data sets. 25,[27][28][29][30] Each study illustrated the potential utility of limitedsampling strategies by requiring only 1 or 2 blood samples to predict AUC, with minimal bias and relatively good precision. The level I studies of didanosine and zidovudine also provided 1-sample limited-sampling strategies to predict a second pharmacokinetic parameter, maximum drug concentration (C max ).…”

“…23,24 Table 2 summarizes the characteristics of the included studies [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] according to their levels of evidence. The following information was extracted from each study: level of evidence, the antiinfective agent, the population for derivation of the limitedsampling strategy, the sampling times investigated, the suggested timed samples, the equation(s) for the limited-sampling strategy, r (the correlation coefficient) or r 2 , the percent bias for the validation group, the percent precision, and additional comments.…”