可比性
产品(数学)
质量(理念)
制造工艺
过程(计算)
计算机科学
过程管理
风险分析(工程)
业务
数学
材料科学
哲学
复合材料
组合数学
操作系统
认识论
几何学
作者
Kavita Ramalingam Iyer,Isabelle Lequeux
出处
期刊:Pda Journal of Pharmaceutical Science and Technology
[Parenteral Drug Association, Inc.]
日期:2020-01-01
卷期号:74 (5): 563-570
被引量:4
标识
DOI:10.5731/pdajpst.2019.010439
摘要
Chemistry, manufacturing, and control postapproval changes are an intrinsic part of the life cycle of pharmaceutical products. In this paper, the authors examined the potential impact of such changes on the product quality, safety, and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety and product safety and efficacy is maintained through the proposed changes. Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is “essentially similar”, what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, two case studies are presented: change to the manufacturing facility of the drug substance, and change to the manufacturing process of a drug substance intermediate and manufacturing facility.
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