Bioanalytical Laboratory, Torrent Pharmaceutical Ltd, Bhat, Gandhinagar-382428, Gujarat, India.
Biopharm Drug Dispos. 2009 Dec;30(9):524-31. doi: 10.1002/bdd.688.
The plasma concentration profile of lamotrigine was predicted from the dissolution test data of the modified release 100 mg lamotrigine tablet by applying the in vitro-in vivo correlation (IVIVC). Three different release formulations (L-1, L-2 and L-3) and its profiles of in vitro data were generated in different dissolution media. Pharmacokinetics evaluation of these formulations was carried out in 12 healthy volunteers. In vitro-in vivo correlation was established from the generated dissolution and bioavailability data. A good correlation between the percentages dissolved vs absorbed (r2>0.989) was obtained using level A correlation. Evaluation of the internal predictability of level A correlation was calculated in terms of percent prediction error, which was found to be below 15%.
采用体外-体内相关性（IVIVC），从改良释放 100mg 拉莫三嗪片的溶出度试验数据预测拉莫三嗪的血浆浓度曲线。在不同的溶出介质中生成了三种不同的释放制剂（L-1、L-2 和 L-3）及其体外数据的曲线。对这些制剂进行了 12 名健康志愿者的药代动力学评估。从生成的溶出度和生物利用度数据中建立了体外-体内相关性。使用级别 A 相关性获得了溶解百分比与吸收百分比之间的良好相关性（r2>0.989）。通过预测误差百分比来计算级别 A 相关性的内部预测能力的评估，发现预测误差百分比低于 15%。
