Factors that impact pharmacokinetic measurements of antibody therapeutics: what is your PK assay telling you?

被引:3
作者
Fischer, Saloumeh Kadkhodayan [1 ]
机构
[1] Genentech Inc, Assay Dev & Technol, 1 DNA Way, San Francisco, CA 94080 USA
关键词
free drug; LBA; ligand binding assay; pharmacokinetics; PK; total drug; DRUG QUANTIFICATION; BEVACIZUMAB; VALIDATION; MODEL;
D O I
10.4155/bio-2017-0173
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
""... assay reagents, format and conditions can significantly impact the PK parameters/profiles for an antibody therapeutic depending on what drug species is being detected.""
引用
收藏
页码:1531 / 1533
页数:3
相关论文
共 11 条
[1]  
[Anonymous], 2013, GUID IND BIOAN METH
[2]   The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters Case studies [J].
Fischer, Saloumeh K. ;
Yang, Jihong ;
Anand, Banmeet ;
Cowan, Kyra ;
Hendricks, Robert ;
Li, Jing ;
Nakamura, Gerald ;
Song, An .
MABS, 2012, 4 (05) :623-631
[3]  
Kuang B, 2010, BIOANALYSIS, V2, P1125, DOI [10.4155/bio.10.64, 10.4155/BIO.10.64]
[4]   Bioanalytical Approaches to Quantify "Total" and "Free" Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development [J].
Lee, Jean W. ;
Kelley, Marian ;
King, Lindsay E. ;
Yang, Jihong ;
Salimi-Moosavi, Hossein ;
Tang, Meina T. ;
Lu, Jian-Feng ;
Kamerud, John ;
Ahene, Ago ;
Myler, Heather ;
Rogers, Cindy .
AAPS JOURNAL, 2011, 13 (01) :99-110
[5]   Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma [J].
Lowe, Philip J. ;
Tannenbaum, Stacey ;
Gautier, Aurelie ;
Jimenez, Pablo .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2009, 68 (01) :61-76
[6]   A pharmacokinetic binding model for bevacizumab and VEGF165 in colorectal cancer patients [J].
Panoilia, Eirini ;
Schindler, Emilie ;
Samantas, Epaminontas ;
Aravantinos, Gerasimos ;
Kalofonos, Haralabos P. ;
Christodoulou, Christos ;
Patrinos, George P. ;
Friberg, Lena E. ;
Sivolapenko, Gregory .
CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2015, 75 (04) :791-803
[7]   Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study [J].
Peng, Kun ;
Xu, Keyang ;
Liu, Luna ;
Hendricks, Robert ;
Delarosa, Reginald ;
Erickson, Rich ;
Budha, Nageshwar ;
Leabman, Maya ;
Song, An ;
Kaur, Surinder ;
Fischer, Saloumeh K. .
MABS, 2014, 6 (06) :1500-1508
[8]   2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3-LBA, biomarkers and immunogenicity) [J].
Richards, Susan ;
Amaravadi, Lakshmi ;
Pillutla, Renuka ;
Birnboeck, Herbert ;
Torri, Albert ;
Cowan, Kyra J. ;
Papadimitriou, Apollon ;
Garofolo, Fabio ;
Satterwhite, Christina ;
Piccoli, Steven ;
Wu, Bonnie ;
Krinos-Fiorotti, Corinna ;
Allinson, John ;
Berisha, Flora ;
Cocea, Laurent ;
Croft, Stephanie ;
Fraser, Stephanie ;
Galliccia, Fabrizio ;
Gorovits, Boris ;
Gupta, Swati ;
Gupta, Vinita ;
Haidar, Sam ;
Hottenstein, Charles ;
Ishii-Watabe, Akiko ;
Jani, Darshana ;
Kadavil, John ;
Kamerud, John ;
Kramer, Daniel ;
Litwin, Virginia ;
Lima Santos, Gustavo Mendes ;
Santos, Lima ;
Nelson, Robert ;
Ni, Yan ;
Pedras-Vasconcelos, Joao ;
Qiu, Yongchang ;
Rhyne, Paul ;
Safavi, Afshin ;
Saito, Yoshiro ;
Savoie, Natasha ;
Scheibner, Kara ;
Schick, Eginhard ;
Siguenza, Patricia Y. ;
Smeraglia, John ;
Staack, Roland F. ;
Subramanyam, Meena ;
Sumner, Giane ;
Thway, Theingi ;
Uhlinger, David ;
Ullmann, Martin ;
Vitaliti, Alessandra .
BIOANALYSIS, 2016, 8 (23) :2475-2496
[9]   Validation of a ligand-binding assay for active protein drug quantification following the 'free analyte QC concept' [J].
Schick, Eginhard ;
Staack, Roland F. ;
Haak, Markus ;
Jordan, Gregor ;
Dahl, Uwe ;
Heinrich, Julia ;
Birnboeck, Herbert ;
Papadimitriou, Apollon .
BIOANALYSIS, 2016, 8 (24) :2537-2549
[10]  
Staack RF, 2012, BIOANALYSIS, V4, P381, DOI [10.4155/BIO.11.321, 10.4155/bio.11.321]