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From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation

Year: 2025

Type: article

Source: The AAPS Journal

DOI: 10.1208/s12248-025-01038-5

Authors: Mianzhi Gu, Andrew Gehman, Brady Nifong, Andrew P. Mayer, Vicky Li, Mary Birchler, Kai Wang, Huaping Tang

Institutions: Otsuka (United States), GlaxoSmithKline (United States)

Language: English

Topic: Biosimilars and Bioanalytical Methods

Subfield: Immunology

Field: Immunology and Microbiology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: closed

OpenAlex ID: W4408045308

FWCI: 2.363

Cites: 10

Cited by: 8

Related to: 10