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mAbs Volume 6, 2014 - Issue 4
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Characterization of a quantitative method to measure free proprotein convertase subtilisin/kexin type 9 in human serum

Alexander Colbert Department of Pharmacokinetics and Drug Metabolism; Amgen Inc.; Seattle, WA USA
,
Amber Umble-Romero Department of Pharmacokinetics and Drug Metabolism; Amgen Inc.; Seattle, WA USA
,
Samantha Prokop Department of Pharmacokinetics and Drug Metabolism; Amgen Inc.; Seattle, WA USA
,
Ren Xu Department of Pharmacokinetics and Drug Metabolism; Amgen Inc.; Seattle, WA USA
,
John P Gibbs Department of Pharmacokinetics and Drug Metabolism; Amgen Inc.; Seattle, WA USA
&
Susan Pederson Department of Pharmacokinetics and Drug Metabolism; Amgen Inc.; Seattle, WA USACorrespondence[email protected]
Pages 1103-1113 | Received 24 Feb 2014, Accepted 31 Mar 2014, Published online: 16 Apr 2014

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Chao Liu, Hong Lu, Fei Yuan, Wei-Li Chen, Hong-Rong Xu, Hui Li, Cheng-Pang Hsu, Ogo Egbuna, Jihua Wu, Clapton Dias, Bassam Abosaleem, Jitesh Rana, Maria Laura Monsalvo, Xue-Ning Li & Zhigang Yu. (2019) A Phase 1, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Safety, Tolerability, And Pharmacokinetic/Pharmacodynamic Study Of Evolocumab In Healthy Chinese Subjects. Clinical Pharmacology: Advances and Applications 11, pages 145-153.
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Tanawan Kongmalai, Nalinee Chuanchaiyakul, Chattip Sripatumtong, Tunsuda Tansit, Yuttana Srinoulprasert, Nareerak Klinsukon & Nuntakorn Thongtang. (2021) The effect of temperature on the stability of PCSK-9 monoclonal antibody: an experimental study. Lipids in Health and Disease 20:1.
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Georgios Louloudis, Samuele Ambrosini, Francesco Paneni, Giovanni G. Camici, Dietmar Benke & Jan Klohs. (2021) Adeno-Associated Virus-Mediated Gain-of-Function mPCSK9 Expression in the Mouse Induces Hypercholesterolemia, Monocytosis, Neutrophilia, and a Hypercoagulative State. Frontiers in Cardiovascular Medicine 8.
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Yun Liu, Ronald Robinson, Thao Ung, Chrysanthe Spais, Justin Schreiber, Jacquelyn Lyons, Jean Husten, Hussein Hallak & Thelma Angeles. (2021) Development of a Meso Scale Discovery ligand-binding assay for measurement of free (drug-unbound) target in nonhuman primate serum. Bioanalysis 13:7, pages 575-585.
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Edward Lee, John P. Gibbs, Maurice G. Emery, Geoffrey Block, Scott M. Wasserman, Lisa Hamilton, Sreeneeranj Kasichayanula, Patrick Hanafin, Ransi Somaratne & Ogo Egbuna. (2019) Influence of Renal Function on Evolocumab Exposure, Pharmacodynamics, and Safety. Clinical Pharmacology in Drug Development 8:3, pages 281-289.
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Meric Ovacik & Kedan Lin. (2018) Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development. Clinical and Translational Science 11:6, pages 540-552.
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Scott M. Wasserman, Marc S. Sabatine, Michael J. Koren, Robert P. Giugliano, Jason C. Legg, Maurice G. Emery, Sameer Doshi, Thomas Liu, Ransi Somaratne & John P. Gibbs. (2018) Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals. Journal of Cardiovascular Pharmacology and Therapeutics 23:5, pages 423-432.
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Sreeneeranj Kasichayanula, Anita Grover, Maurice G. Emery, Megan A. Gibbs, Ransi Somaratne, Scott M. Wasserman & John P. Gibbs. (2018) Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clinical Pharmacokinetics 57:7, pages 769-779.
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John P. Gibbs, Sameer Doshi, Mita Kuchimanchi, Anita Grover, Maurice G. Emery, Michael G. Dodds, Megan A. Gibbs, Ransi Somaratne, Scott M. Wasserman & Dirk Blom. (2016) Impact of Target‐Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9). The Journal of Clinical Pharmacology 57:5, pages 616-626.
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John P. Gibbs, J. Greg Slatter, Ogo Egbuna, Michelle Geller, Lisa Hamilton, Clapton S. Dias, Ren Y. Xu, Jessica Johnson, Scott M. Wasserman & Maurice G. Emery. (2017) Evaluation of Evolocumab (AMG 145), a Fully Human Anti-PCSK9 IgG2 Monoclonal Antibody, in Subjects With Hepatic Impairment. The Journal of Clinical Pharmacology 57:4, pages 513-523.
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Gerald F. WattsDick C. ChanRicardo DentRansi SomaratneScott M. WassermanRob ScottSally BurrowsP. Hugh R. Barrett. (2017) Factorial Effects of Evolocumab and Atorvastatin on Lipoprotein Metabolism. Circulation 135:4, pages 338-351.
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Fang Xie, Maurice G Emery, John P Gibbs, Dan A Rock & Brooke M Rock. (2016) SRM-based measurements of proprotein convertase subtilisin/kexin type 9 and lipoprotein(a) kinetics in nonhuman primate serum. Bioanalysis 8:24, pages 2551-2563.
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Macarena Fritz Kelly. (2016) Antibody Validation. Materials and Methods 6.
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Teik Chye Ooi & Hussein Abujrad. 2016. Biomarkers in Cardiovascular Disease. Biomarkers in Cardiovascular Disease 125 151 .
Xuemei Zhao, Vijay Modur, Leonidas N Carayannopoulos & Omar F Laterza. (2015) Biomarkers in Pharmaceutical Research. Clinical Chemistry 61:11, pages 1343-1353.
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Teik Chye Ooi & Hussein Abujrad. 2015. Biomarkers in Cardiovascular Disease. Biomarkers in Cardiovascular Disease 1 27 .

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