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基准模型,模型验证和应用步骤的 PBBM 考虑: 研讨会总结报告

Tycho Heimbach¹, Flora Musuamba Tshinanu², Kimberly Raines³

¹Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States.

Molecular pharmaceutics

|September 30, 2024

概括

基于生理学的生物制药模型 (PBBM) 对药物产品质量进行了探索,重点关注监管和行业最佳实践. 案例研究表明,PBBM在定义规范和确保生物等价性方面的应用.

科学领域:

药理动力学和药物新陈代谢
制药科学制药科学
监管科学监管科学

背景情况:

研讨会重点关注生理基础生物制药模型 (PBBM) 药物产品质量的最佳实践.
第二天专门讨论了PBBM应用的监管和行业观点.

研究的目的:

提供2023年8月30日关于PBBM的研讨会的记录.
分享关于 PBBM 验证,验证和应用的案例研究和经验.
讨论目前的趋势和阻碍在PBBM实施中的障碍.

主要方法:

审查六个监管机构的PBBM案例研究.
讨论可信度评估框架,使用上下文 (COU) 和模型风险评估.
突破会议涉及PBBM验证,处置参数,虚拟生物等价性试验和接受标准.

主要成果:

案例研究表明,PBBM用于定义关键材料属性 (CMA),如粒子大小分布 (PSD).
提交了PBBM应用程序,用于定义关键质量属性 (CQA),溶解规格和生物等价安全空间.
从案例研究和突破性会议中得出的教训确定了PBBM实施的关键考虑因素.

结论:

PBBM为药品质量评估提供了有价值的工具,从物质属性到生物等价性.
有效的应用需要强有力的验证,验证和清晰的使用上下文.
解决与可信度,数据可用性和虚拟试验执行有关的障碍对于更广泛的采用至关重要.

关键词:

生物等价性生物等价性 IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVR IVIVR 在线视频美国的 PBBM PBBM 生物等效安全空间空间安全空间使用的使用上下文.溶解溶解是一种药物产品质量药物产品质量模型可信度评估框架模型可信度评估框架建模建模模型建模模型

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