产品生命周期
计算机科学
透视图(图形)
新产品开发
产品(数学)
风险分析(工程)
系统工程
过程(计算)
制造工程
过程管理
质量(理念)
出处
期刊:Pda Journal of Pharmaceutical Science and Technology
[Parenteral Drug Association, Inc.]
日期:2021-01-01
卷期号:: pdajpst.2021.012647-pdajpst.2021.012647
标识
DOI:10.5731/pdajpst.2021.012647
摘要
The number of products being developed for serious conditions that are eligible for expedited programs has been increasing in recent years. This article presents an industry perspective on how to reduce analytical life cycle steps when using analytical platform technologies (APT) in support of accelerated biological product development. Strategies for life cycle steps for APT methods are conceptually reviewed within the framework of supporting chemistry, manufacturing, and control (CMC) development acceleration. Reduced method qualification, transfer, and validation studies could be performed, provided that the initially validated test method remains unchanged. A detailed case study is used to illustrate considerations for the initial method validation and subsequent APT verification studies. Considerations for APT implementation are discussed and suggestions are provided for the submission of APT information in regulatory filings.
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