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Validation and Correlation Strategies for Data Generated by Ligand Binding Assays and LC-MS to Support Product Development and Regulatory Studies

机译:用配体结合测定和LC-MS产生的数据验证和相关策略,以支持产品开发和监管研究

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摘要

Both immunochemistry (such as ELISA) and LC-MS methodologies are important analytical tools in the biotechnology product development cycle. It is necessary to correlate data generated by both technologies early in product development to allow either technology to support specific questions from discovery through deregulation.
机译:免疫化学(如ELISA)和LC-MS方法都是生物技术产品开发周期中的重要分析工具。有必要将两种技术在产品开发中产生的数据相关,以允许通过放松管制来支持发现特定问题。

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