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The AAPS Journal|April 2, 2014
Ligand binding assay critical reagents and their stability: recommendations and best practices from the Global Bioanalysis Consortium Harmonization TeamLindsay E King, Esme Farley, Mami Imazato, et al.Analytical Biochemistry|December 3, 2014
A multifactorial screening strategy to identify anti-idiotypic reagents for bioanalytical support of antibody therapeuticsHossein Salimi-Moosavi, Aaron Winters, Christina Abbott, et al.Journal of Pharmaceutical and Biomedical Analysis|January 20, 2009
Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisionsTheingi M Thway, Mark Ma, Jean Lee, et al.Journal of Pharmaceutical and Biomedical Analysis|January 20, 2009
Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteinsChad A Ray, Vimal Patel, Judy Shih, et al.Bioanalysis|March 20, 2019
Bioanalytical challenges and unique considerations to support pharmacokinetic characterization of bispecific biotherapeuticsMark Ma, Kelly Colletti, Tong-Yuan Yang, et al.Bioanalysis|November 19, 2010
Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromoleculesTheingi M Thway, Chris R Macaraeg, Dominador Calamba, et al.The AAPS Journal|October 12, 2012
Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changesRamak Pourvasei, Ed Lee, Michael Eschenberg, et al.Clinical Pharmacokinetics|November 18, 2011
Population pharmacokinetic meta-analysis of denosumab in healthy subjects and postmenopausal women with osteopenia or osteoporosisLiviawati Sutjandra, Rachelle D Rodriguez, Sameer Doshi, et al.The AAPS Journal|August 26, 2010
Pharmacokinetics of anti-hepcidin monoclonal antibody Ab 12B9m and hepcidin in cynomolgus monkeysJim J Xiao, Wojciech Krzyzanski, Yow-Ming Wang, et al.Journal of Pharmaceutical and Biomedical Analysis|May 12, 2010
A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteinsChad A Ray, Lei Zhou, Jennifer Tsoi, et al.Pageof 6