Research Topics
| Jean W LeeSummaryAffiliation: MDS Pharma Services Country: USA Publications
| Collaborators
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Detail Information
Publications
Fit-for-purpose method development and validation for successful biomarker measurementJean W Lee
Formerly MDS Pharma Services, Lincoln, Nebraska, USA
Pharm Res 23:312-28. 2006..Sample analysis within this context of fit-for-purpose method development and validation are well suited for successful biomarker implementation, allowing increased use of biomarkers in drug development...
Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkersJean W Lee
Amgen Inc, Thousand Oaks, California 91320, USA
Adv Cancer Res 96:269-98. 2007..Specific references to protein biomarkers for cancer drug development are also discussed...
Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference reportJean W Lee
MDS Pharma Services, Lincoln, Nebraska, USA
Pharm Res 22:499-511. 2005....
Supercritical fluid chromatography-tandem mass spectrometry for fast bioanalysis of R/S-warfarin in human plasmaRoger A Coe
MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
J Pharm Biomed Anal 42:573-80. 2006..0% C.V. for S-warfarin; and the bias was 3.7 and 3.2% R.E., respectively. The method is sensitive, accurate, selective and robust, and was applied to a drug-interaction clinical study with rapid turnaround of sample analysis...
Biomarkers, validation and pharmacokinetic-pharmacodynamic modellingWayne A Colburn
MDS Pharma Services, Phoenix, Arizona, USA
Clin Pharmacokinet 42:997-1022. 2003....
Quantification of uric acid, xanthine and hypoxanthine in human serum by HPLC for pharmacodynamic studiesNancy Cooper
MDS Pharma Services, Lincoln, NE 68501, USA
J Chromatogr B Analyt Technol Biomed Life Sci 837:1-10. 2006..The method was simple and robust with good accuracy and precision for the measurement of serum UA, X, and HX concentrations...
Quantification of recombinant human parathyroid hormone (rhPTH(1-84)) in human plasma by immunoassay: commercial kit evaluation and validation to support pharmacokinetic studiesRichard L Sukovaty
MDS Pharma Services, Lincoln, NE, USA
J Pharm Biomed Anal 42:261-71. 2006....
A general approach for the quantitative analysis of bisphosphonates in human serum and urine by high-performance liquid chromatography/tandem mass spectrometryLee S Zhu
MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
Rapid Commun Mass Spectrom 20:3421-6. 2006..The general applicability of the approach was demonstrated by validation of bioanalytical methods for risedronate and alendronate in human serum and urine. Sensitivity was achieved at the pg/mL level with merely 100-200 microL of sample...
