Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics

Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena

Volumn , Issue , 2009, Pages 81-110

  Desilva, Binodh S ^a   Bowsher, Ronald R ^b  

^a AMGEN INC   (United States)

^b Millipore   (United States)

Author keywords

Analytical performance characteristics in prestudy validation phase; Ligand binding assays supporting biotherapeutic pharmacokinetic assessments; Robustness ruggedness investigation withstanding standard laboratory condition changes

Indexed keywords

EID: 79955453897     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470541517.ch4     Document Type: Chapter

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