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Pharm Res. 2005 Sep;22(9):1425-31. Epub 2005 Aug 24.

Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.

Author information

1
Alta Analytical Laboratory, San Diego, California, USA. josmolec@alta-immunochem.com

Abstract

The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.

PMID:
16132353
DOI:
10.1007/s11095-005-5917-9
[Indexed for MEDLINE]

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