Development and verification of mechanistic vaginal absorption and metabolism (MechVAM) model to predict systemic exposure after vaginal ring and gel application

The current data contains workspace files and excel outputs related to the development and verification of mechanistic vaginal absorption and metabolism (MechVAM) model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations. There was an adequate number of studies for dapivirine (DPV), etonogestrel (ETO) and ethinyl estradiol (EE) ring formulations while tenofovir (TFV), lidocaine (LID) and dapivirine (DPV) have reported clinical data for intravaginal gel formulations. The data includes files for the development and verification of intravenous and oral models for the above-mentioned molecules followed by the PBPK model development for intravaginal route of administration.本数据集包含与Simcyp模拟器（Simcyp Simulator）内机制性阴道吸收与代谢（MechVAM）模型开发及验证相关的工作区文件与Excel输出文件，该模型用于预测阴道给予环形制剂与凝胶制剂后的全身血药浓度。针对达匹韦林（DPV）、依托孕烯（ETO）及炔雌醇（EE）的环形制剂，已有充足的相关研究数据；而替诺福韦（TFV）、利多卡因（LID）与达匹韦林（DPV）的阴道内凝胶制剂则已公开临床研究数据。本数据集涵盖上述药物分子的静脉给药与口服给药模型的开发及验证所需文件，后续还包含阴道给药途径的生理药代动力学（Physiologically Based Pharmacokinetic, PBPK）模型的开发相关文件。

搜集汇总

背景与挑战

背景概述

该数据集包含用于开发和验证机制性阴道吸收和代谢（MechVAM）模型的工作区文件和Excel输出，旨在预测阴道环和凝胶给药后的系统暴露浓度。它涵盖了多种药物（如dapivirine、etonogestrel、ethinyl estradiol、tenofovir、lidocaine）的临床数据，支持静脉、口服及阴道给药途径的PBPK模型开发，适用于凝胶、阴道药物递送、系统药代动力学和阴道疾病相关研究。