Balimane Praveen V, Marino Anthony, Chong Saeho
Metabolism and Pharmacokinetics, Bristol-Myers Squibb, P.O. Box # 4000, Mailstop: F.13-07, Route 206 & Province Line Road, Princeton, New Jersey 08543, USA.
AAPS J. 2008 Dec;10(4):577-86. doi: 10.1208/s12248-008-9068-x. Epub 2008 Dec 11.
The objective was to directly compare the four different "calculation" methods of assessing P-gp inhibition potential using experimental data obtained from approximately 60 structurally diverse internal research and marketed compounds. Bidirectional studies for digoxin (probe for P-gp substrate) were performed with and without test compounds (at 10 microM). Four different calculation methods were applied to the same dataset (raw bidirectional permeability values) to obtain the "percent inhibition of P-gp" for these compounds using the different methods. Significantly different inhibition potential was obtained with the "exact" same experimental dataset depending on the calculation method used. Subsequently, entirely different conclusions regarding the "inhibition potential" of test compound was reached due to the different calculation methods. Based on the direct comparison of these methods, method no. 3 (i.e., inhibition of B to A permeability of digoxin) is recommended as the calculation method ideal during screening stages due to its high throughput amenability. The methodology is capable of rapidly screening compounds with adequate reliability for early stage drug discovery. Method no. 3 provides an abridged version of a bidirectional study that is fully capable of identifying all non-inhibitors (0-20%), moderate inhibitors (20-60%), and potent inhibitors (>60%) and demonstrates high correlation with method no. 1 (inhibition based on both A to B and B to A permeability of digoxin). Nevertheless, method no. 1 might be appropriate for more detailed mechanistic studies required in late stage discovery and development.
目的是使用从大约60种结构各异的内部研究化合物和市售化合物获得的实验数据,直接比较评估P-糖蛋白抑制潜力的四种不同“计算”方法。对P-糖蛋白底物地高辛进行了双向研究,分别在有和没有测试化合物(10μM)的情况下进行。将四种不同的计算方法应用于同一数据集(原始双向渗透率值),以使用不同方法获得这些化合物的“P-糖蛋白抑制百分比”。根据所使用的计算方法,使用“完全相同”的实验数据集获得了显著不同的抑制潜力。随后,由于计算方法不同,得出了关于测试化合物“抑制潜力”的完全不同的结论。基于这些方法的直接比较,推荐方法3(即抑制地高辛从B到A的渗透率)作为筛选阶段理想的计算方法,因为它具有高通量适应性。该方法能够以足够的可靠性快速筛选化合物,用于早期药物发现。方法3提供了双向研究的简化版本,完全能够识别所有非抑制剂(0-20%)、中度抑制剂(20-60%)和强效抑制剂(>60%),并与方法1(基于地高辛从A到B和从B到A的渗透率的抑制)显示出高度相关性。然而,方法1可能适用于后期发现和开发所需的更详细的机制研究。