Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping.
Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping.
复制标题
研究人员通过胶带剥离对角质层采样中药物生物利用度的重现性的影响。
DOI：
10.1007/s11095-022-03199-w
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发表时间：
2022
影响因子：
3.7
通讯作者：
Stinchcomb,AudraL
中科院分区：
文献类型：
--
作者：
Shukla,Sagar;Bunge,AnnetteL;Hassan,HazemE;Stinchcomb,AudraL
目的：通过胶带剥离皮肤取样测量局部药物产品在角质层（SC）中的局部生物利用度。目前的研究的目标是评估不同的研究人员的影响，利用磁带剥离协议，旨在尽量减少调查variation.MethodsTwo开放标签的临床研究比较了两个利多卡因补丁和双氯芬酸补丁和解决方案在12名健康志愿者。由两名研究者一式两份在产品取出后的三个时间点在胶带条上收集的SC样品中测定药物质量。研究者的结果进行了比较，并与其他实验室使用类似protocol.ResultsFor药物质量测量的双氯芬酸溶液的结果，比较两个研究者的几何平均值比是在可接受的生物等效性区间内的大多数测量时间和药物产品。从双氯芬酸溶液进入SC的药物摄取量与另一个实验室测定的结果无统计学差异。四种药物产品的清除间隔从SC的平均通量对应以及从体外渗透tests.ConclusionsResults的通量测量是可重复的测量变异性，这可以通过增加志愿者人数的限制内。
PurposeSkin sampling by tape stripping measures the local bioavailability of topical drug products in the stratum corneum (SC). The goal of the current study was to evaluate the impact of different investigators in studies that utilize a tape stripping protocol designed to minimize investigator variability.MethodsTwo open-label clinical studies compared two lidocaine patches and a diclofenac patch and solution in twelve healthy volunteers. The mass of drug was determined in SC samples collected on tape strips at three time points following product removal in duplicate by two investigators. Investigator results were compared with each other and with results for the diclofenac solution measured by another laboratory using a similar protocol.ResultsFor drug mass, the geometric mean ratio comparing two investigators is within the acceptable bioequivalence interval for most measurement times and drug products. Drug uptake into the SC from the diclofenac solution was not statistically different from that determined in another laboratory. The average flux from the SC over the clearance intervals for the four drug products correspond well with flux measurements from in vitro permeation tests.ConclusionsResults from different investigators are reproducible within the limitations of measurement variability, which can be managed by increasing volunteer numbers.