Bowsher R - Search Results

1

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.

Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E. Shankar G, et al. Among authors: bowsher r. J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. doi: 10.1016/j.jpba.2008.09.020. Epub 2008 Sep 19. J Pharm Biomed Anal. 2008. PMID: 18993008 Review.

2

Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum.

Ray CA, Bowsher RR, Smith WC, Devanarayan V, Willey MB, Brandt JT, Dean RA. Ray CA, et al. Among authors: bowsher rr. J Pharm Biomed Anal. 2005 Jan 4;36(5):1037-44. doi: 10.1016/j.jpba.2004.05.024. J Pharm Biomed Anal. 2005. PMID: 15620530

3

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: bowsher rr. 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

4

A sensitive chemiluminescent enzyme immunoassay for the bioanalysis of carboxyl-terminal B-chain analogues of human insulin.

Cao Y, Smith WC, Bowsher RR. Cao Y, et al. Among authors: bowsher rr. J Pharm Biomed Anal. 2001 Aug;26(1):53-61. doi: 10.1016/s0731-7085(01)00345-4. J Pharm Biomed Anal. 2001. PMID: 11451642

5

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points.

Devanarayan V, Smith WC, Brunelle RL, Seger ME, Krug K, Bowsher RR. Devanarayan V, et al. Among authors: bowsher rr. AAPS J. 2017 Sep;19(5):1487-1498. doi: 10.1208/s12248-017-0107-3. Epub 2017 Jul 21. AAPS J. 2017. PMID: 28733862

6

Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?

Bowsher RR, Devanarayan V. Bowsher RR, et al. AAPS J. 2020 Oct 6;22(6):127. doi: 10.1208/s12248-020-00510-8. AAPS J. 2020. PMID: 33025311 Free PMC article. No abstract available.

7

Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.

Smolec J, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, Khan M, Tacey R, Hill H, Celniker A, Shah V, Bowsher R, Mire-Sluis A, Findlay JW, Saltarelli M, Quarmby V, Lansky D, Dillard R, Ullmann M, Keller S, Karnes HT. Smolec J, et al. Among authors: bowsher r. Pharm Res. 2005 Sep;22(9):1425-31. doi: 10.1007/s11095-005-5917-9. Epub 2005 Aug 24. Pharm Res. 2005. PMID: 16132353 Review.

8

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. Among authors: bowsher rr. Bioanalysis. 2015;7(2):229-42. doi: 10.4155/bio.14.274. Bioanalysis. 2015. PMID: 25587839 Free article.

9

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. Among authors: bowsher rr. Pharm Res. 2005 Apr;22(4):499-511. doi: 10.1007/s11095-005-2495-9. Epub 2005 Apr 7. Pharm Res. 2005. PMID: 15846456

10

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: bowsher rr. Pharm Res. 2001 Sep;18(9):1373-83. doi: 10.1023/a:1013062600566. Pharm Res. 2001. PMID: 11683255 No abstract available.

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