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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.
Analytical Chemistry|January 17, 2012
General LC-MS/MS method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studiesHongyan Li, Robert Ortiz, Linh Tran, et al.
The AAPS Journal|July 14, 2010
Ligand-binding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptorMichael P Hall, Colin Gegg, Kenneth Walker, et al.
The AAPS Journal|January 18, 2011
Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug developmentJean W Lee, Marian Kelley, Lindsay E King, et al.
The AAPS Journal|November 14, 2014
Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeuticsRand Jenkins, Jeffrey X Duggan, Anne-Françoise Aubry, et al.
Human Molecular Genetics|September 25, 2012
Polycystin-1 regulates the stability and ubiquitination of transcription factor Jade-1Rebecca L Foy, Vipul C Chitalia, Maria V Panchenko, et al.
Pharmaceutical Research|January 7, 2006
Fit-for-purpose method development and validation for successful biomarker measurementJean W Lee, Viswanath Devanarayan, Yu Chen Barrett, et al.
Pharmaceutical Research|April 23, 2005
Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference reportJean W Lee, Russ S Weiner, Jeff M Sailstad, et al.
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