Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Springer Science and Business Media LLC - 2003
Binodh DeSilva1, Wendell C. Smith2, Russell Weiner3, Marian Kelley4, JoMarie Smolec5, Ben Liu6, Masood Khan7, Richard Tacey8, Howard Hill9, Abbie Celniker10
1Amgen, Inc., Thousand Oaks
2Lilly Research Laboratories, Greenfield, Indiana
3Bristol Myers Squibb, Princeton, New Jersey
4Johnson and Johnson Pharmaceutical, Raritan
5Alta Analytical Laboratory, San Diego
6Pfizer Global Research and Development, Ann Arbor
7Covance Laboratories, Chantilly
8PPD Development, Richmond, Virginia
9HLS, Cambridgeshire, UK
10Millennium Pharmaceuticals, Cambridge

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