杠杆(统计)
风险分析(工程)
质量(理念)
产品(数学)
患者安全
模式
相关性(法律)
过程管理
医学
计算机科学
业务
医疗保健
哲学
认识论
几何学
政治学
数学
社会科学
经济增长
机器学习
社会学
经济
法学
作者
Anthony R. Mire‐Sluis,James T. Dobbins,Christine Moore,Teresa Pepper,Barbara L. Rellahan,Ken Riker,Marc J. Roberts,Thomas Schultz
标识
DOI:10.1016/j.xphs.2024.01.006
摘要
To ensure the quality, safety and efficacy of medicinal products, it is necessary to develop and execute appropriate manufacturing process and product control strategies. Traditionally, product control strategies have focused on testing known quality attributes with limits derived from levels administered in preclinical and clinical studies with an associated statistical analysis to account for variability. However, not all quality attributes have impact to the patient and those with the potential to impact safety and efficacy may not be significant when dosed at patient-centric levels. Therefore, achieving patient-centricity is understanding patient relevance, which is defined as the level of impact that a quality attribute could have on safety and efficacy within the potential exposure range. A patient-centric quality standard (PCQS) is therefore a set of patient relevant attributes and their associated acceptance ranges to which a drug product should conform within the expected patient exposure range. This manuscript describes historical perspectives details the way to create and leverage a PCQS in a variety of pharmaceutical product modalities.
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