Pharmacokinetics

Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.
Mitra Azadeh, Boris Gorovits, John Kamerud, Stephen MacMannis, Afshin Safavi, Jeffrey Sailstad, Perceval Sondag. AAPS J 2018 Jan; 20:22- Open Access White Paper.Access Here

Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study.
Curtin F, Vidal V, Bernard C, Kromminga A, Lang AB, Porchet H. MAbs. 2016 Jul;8(5):854-60.
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eBook: Bioanalysis for Biosimilars Development
Gouty, 2015. Bioanalysis Zone.
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Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein.
Curtin F, Perron H, Kromminga A, Porchet H, Lang AB. MAbs. 2015;7(1):265-75.
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Recommendations on incurred sample stability (ISS) by GCC.
Lowes S, Gouty D, et al. Bioanalysis. 2014 Sep;6(18):2385-90. doi: 10.4155/bio.14.155.
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Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. AAPS J. 2014 Nov; 16(6):1149-58. doi: 10.1208/s12248-014-9669-5. Epub 2014 Oct 3.
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2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
DeSilva B, Gouty D, et al. Bioanalysis. 2012 Sep; 4(18):2213-26. doi: 10.4155/bio.12.205.
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