基于生理的生物制药建模(PBBM)用于通过提供对药物如何与人体相互作用的更准确和全面的理解来提高药物产品质量。这些模型是基于生理的整合,药理学,和药物数据来模拟和预测体内药物行为。有效利用PBBM需要一致的模型开发方法,验证,验证,和应用。目前,只有一个国家有PBBM指导文件草案,而其他主要监管机构在PBBM审查方面的经验有限。为了解决这个差距,业界提交了机密的PBBM案例研究,由监管机构审查;软件公司致力于培训。PBBM案件由监管机构独立合作讨论,和学术同事参加了一些讨论。还介绍了成功的生物等效性“安全空间”行业案例。总的来说,六个监管机构参与了案例研究,包括ANVISA,FDA,加拿大卫生部,MHRA,PMDA,和EMA(来自比利时的专家,德国,挪威,葡萄牙,西班牙,和瑞典),我们相信这是第一次这样的合作。在本次研讨会上介绍了成果,连同一项关于PBBM提交的效用和经验的参与者调查,讨论发展的最佳科学实践,正在验证,和应用PBBM。PBBM案例研究使行业能够从全球监管机构获得建设性的反馈,并为未来的PBBM提交给监管机构考虑强调了明确的方向。
Physiologically based
biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence \"safe space\" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration.