Volume 11; Issue 24

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Bioanalysis
Volume 11; Issue 24

Bioanalysis

Volume 11; Issue 24

1

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Piccoli, Steven, Mehta, Devangi, Vitaliti, Alessandra, Allinson, John, Amur, Shashi, Eck, Steve, Green, Cherie, Hedrick, Michael, Hopper, Shirley, Ji, Allena, Joyce, Alison, Litwin, Virginia, Maher, K

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Year:

2019

File:

PDF, 743 KB

2019

2

Analytical techniques for metabolomic studies: a review

Segers, Karen, Declerck, Sven, Mangelings, Debby, Heyden, Yvan Vander, Eeckhaut, Ann Van

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2019

File:

PDF, 2.39 MB

2019

3

Application of multiplexed pharmacokinetic immunoassay to quantify in vivo drug forms and coadministered biologics

Woodbury, Nicole, Bald, Eric, Geist, Brian, Yang, Tong-Yuan

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Year:

2019

File:

PDF, 724 KB

2019

4

LC–MS/MS method for simultaneous determination of rivaroxaban and metformin in rat plasma: application to pharmacokinetic interaction study

Gai, Shouchang, Huang, Anli, Feng, Tian, Gou, Nan, Wang, Xingchen, Lu, Chunling, Tang, Hongyun, Xu, Dapeng, Zhang, Binbin, Wang, Libin

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Year:

2019

File:

PDF, 659 KB

2019

5

Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products

Bano, Nazneen, McKelvey, Troy, Spear, Nathan, Yang, Tong-Yuan, Shankar, Gopi, Schantz, Allen

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Year:

2019

File:

PDF, 289 KB

2019

6

Workshop on Recent Issues in Bioanalysis (WRIB) Poster Award winners 2019

Darling, Ryan, Bonner, Eric, Li, Pei

Journal:

Year:

2019

File:

PDF, 3.55 MB

2019