Boris Gorovits

发表

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Renuka Pillutla, Viswanath Devanarayan, An Song, 2015, Bioanalysis.

Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Heather Myler, Clare Kingsley, Boris Gorovits, 2013, The AAPS Journal.

Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves

Jeffrey Sailstad, Boris Gorovits, John Kamerud, 2017, The AAPS Journal.

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Neil Henderson, Rong Zeng, Renuka Pillutla, 2018, Bioanalysis.

Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper.

Surinder Kaur, Shobha Purushothama, Sanela Bilic, 2013, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Lindsay King, Roger Hayes, Surinder Kaur, 2014, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Lindsay King, Stacy Ho, Roger Hayes, 2014, Bioanalysis.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

Stacy Ho, Roger Hayes, Eric Woolf, 2013, Bioanalysis.

Immunogenicity: prediction, detection and effective assay development.

Boris Gorovits, 2010, Bioanalysis.

A Simple Approach to Determine a Curve Fitting Model with a Correct Weighting Function for Calibration Curves in Quantitative Ligand Binding Assays

Boris Gorovits, John Kamerud, Yuhong Xiang, 2018, The AAPS Journal.

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

Viswanath Devanarayan, Michele Fiscella, Lakshmi Amaravadi, 2008, Journal of pharmaceutical and biomedical analysis.

Bioanalysis of antibody–drug conjugates

Boris Gorovits, B. Gorovits, 2013 .

Antibody-targeted chemotherapy with CMC-544: a CD22-targeted immunoconjugate of calicheamicin for the treatment of B-lymphoid malignancies.

Boris Gorovits, P. Frost, S. Stephens, 2004, Blood.

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics.

Renuka Pillutla, Boris Gorovits, Eric Wakshull, 2014, Journal of immunological methods.

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

Viswanath Devanarayan, Boris Gorovits, Michael Moxness, 2008, Journal of immunological methods.

Prevalence and Isotypic Complexity of the Anti-Chinese Hamster Ovary Host Cell Protein Antibodies in Normal Human Serum

Boris Gorovits, Li Xue, B. Gorovits, 2010, The AAPS Journal.

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Eric Woolf, Binodh DeSilva, Lauren Stevenson, 2014, The AAPS Journal.

Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation

Boris Gorovits, John Kamerud, Marian Kelley, 2013, The AAPS Journal.