Lee JW - Search Results

1

Fit-for-purpose method development and validation for successful biomarker measurement.

Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA. Lee JW, et al. Pharm Res. 2006 Feb;23(2):312-28. doi: 10.1007/s11095-005-9045-3. Epub 2006 Jan 12. Pharm Res. 2006. PMID: 16397743

2

Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report.

Lee JW, Weiner RS, Sailstad JM, Bowsher RR, Knuth DW, O'Brien PJ, Fourcroy JL, Dixit R, Pandite L, Pietrusko RG, Soares HD, Quarmby V, Vesterqvist OL, Potter DM, Witliff JL, Fritche HA, O'Leary T, Perlee L, Kadam S, Wagner JA. Lee JW, et al. Pharm Res. 2005 Apr;22(4):499-511. doi: 10.1007/s11095-005-2495-9. Epub 2005 Apr 7. Pharm Res. 2005. PMID: 15846456

3

Workshop on bioanalytical methods validation for macromolecules: summary report.

Miller KJ, Bowsher RR, Celniker A, Gibbons J, Gupta S, Lee JW, Swanson SJ, Smith WC, Weiner RS. Miller KJ, et al. Among authors: lee jw. Pharm Res. 2001 Sep;18(9):1373-83. doi: 10.1023/a:1013062600566. Pharm Res. 2001. PMID: 11683255 No abstract available.

4

Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development.

Khan MU, Bowsher RR, Cameron M, Devanarayan V, Keller S, King L, Lee J, Morimoto A, Rhyne P, Stephen L, Wu Y, Wyant T, Lachno DR. Khan MU, et al. Bioanalysis. 2015;7(2):229-42. doi: 10.4155/bio.14.274. Bioanalysis. 2015. PMID: 25587839

5

Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins.

Ray CA, Patel V, Shih J, Macaraeg C, Wu Y, Thway T, Ma M, Lee JW, Desilva B. Ray CA, et al. Among authors: lee jw. J Pharm Biomed Anal. 2009 Feb 20;49(2):311-8. doi: 10.1016/j.jpba.2008.11.039. Epub 2008 Dec 6. J Pharm Biomed Anal. 2009. PMID: 19150188

6

Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification.

Pandya K, Ray CA, Brunner L, Wang J, Lee JW, DeSilva B. Pandya K, et al. Among authors: lee jw. J Pharm Biomed Anal. 2010 Nov 2;53(3):623-30. doi: 10.1016/j.jpba.2010.04.025. Epub 2010 Apr 28. J Pharm Biomed Anal. 2010. PMID: 20483557

7

A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins.

Ray CA, Zhou L, Tsoi J, Uy L, Gu J, Malella J, Desimone D, Gunn H, Ma M, Lee J, DeSilva B. Ray CA, et al. J Pharm Biomed Anal. 2010 Nov 2;53(3):729-34. doi: 10.1016/j.jpba.2010.04.022. Epub 2010 Apr 24. J Pharm Biomed Anal. 2010. PMID: 20457502

8

Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics.

Lee JW. Lee JW. Bioanalysis. 2009 Nov;1(8):1461-74. doi: 10.4155/bio.09.130. Bioanalysis. 2009. PMID: 21083095 Review.

9

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.

Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, Khan MN, Bowsher RR. Findlay JW, et al. Among authors: lee jw. J Pharm Biomed Anal. 2000 Jan;21(6):1249-73. doi: 10.1016/s0731-7085(99)00244-7. J Pharm Biomed Anal. 2000. PMID: 10708409

10

"Fit-for-purpose" method validation and application of a biomarker (C-terminal telopeptides of type 1 collagen) in denosumab clinical studies.

Wang J, Lee J, Burns D, Doherty D, Brunner L, Peterson M, DeSilva B. Wang J, et al. AAPS J. 2009 Jun;11(2):385-94. doi: 10.1208/s12248-009-9115-2. Epub 2009 May 22. AAPS J. 2009. PMID: 19462251 Free PMC article.

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