Aburub Aktham, Chen Yuan, Chung John, Gao Ping, Good David, Hansmann Simone, Hawley Michael, Heimbach Tycho, Hingle Martin, Kesisoglou Filippos, Li Rong, Rose John, Tisaert Christophe
Eli Lilly and Company, Indianapolis, Indiana, USA.
Genentech, San Francisco, California, USA.
AAPS J. 2022 Mar 29;24(3):49. doi: 10.1208/s12248-022-00699-w.
Assessment of bioperformance to inform formulation selection and development decisions is an important aspect of drug development. There is high demand in the pharmaceutical industry to develop an efficient and streamlined approach for better understanding and predicting drug product performance to support acceleration of clinical timelines. This manuscript presents an effort from the IQ Formulation Bioperformance Prediction Working Group composed of members from 12 pharmaceutical companies under the IQ Consortium to develop a database around the topic of formulation bioperformance prediction and report findings from the database analysis. Six case studies described in the manuscript demonstrate how bioperformance models were used to predict in vivo performance and to provide guidance addressing questions encountered during oral solid dosage form development. The case studies also described findings of a correlation between in vitro dissolution and in vivo performance and how dissolution data can be incorporated into physiologically based biopharmaceutical modeling. Finally, a workflow for how in vitro dissolution data can be utilized to predict clinical bioperformance of oral solid dosage forms is proposed.
评估生物性能以指导制剂选择和开发决策是药物开发的一个重要方面。制药行业对开发一种高效、简化的方法有很高的需求，以便更好地理解和预测药品性能，从而支持加速临床进程。本手稿展示了由IQ联盟下12家制药公司的成员组成的IQ制剂生物性能预测工作组在围绕制剂生物性能预测主题开发数据库以及报告数据库分析结果方面所做的努力。手稿中描述的六个案例研究展示了生物性能模型如何用于预测体内性能，并为解决口服固体制剂开发过程中遇到的问题提供指导。案例研究还描述了体外溶出与体内性能之间相关性的研究结果，以及溶出数据如何纳入基于生理学的生物药剂学建模。最后，提出了一种利用体外溶出数据预测口服固体制剂临床生物性能的工作流程。
