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Research ArticleMinireview

Current Approaches for ADME Characterization of Antibody-Drug Conjugates: An Industry White Paper

Eugenia Kraynov, Amrita V Kamath, Markus Walles, Edit Tarcsa, Antoine Deslandes, Ramaswamy A Iyer, Amita Datta-Mannan, Priya Sriraman, Michaela Bairlein, Johnny J Yang, Matthew Barfield, Guangqing Xiao, Enrique Escandon, Weirong Wang, Dan A Rock, Nagendra V Chemuturi and David J Moore
Drug Metabolism and Disposition December 15, 2015, dmd.115.068049; DOI: https://doi.org/10.1124/dmd.115.068049
Eugenia Kraynov
1 Pfizer Inc;
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  • For correspondence: eugenia.kraynov@pfizer.com
Amrita V Kamath
2 Genentech;
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Markus Walles
3 Novartis;
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Edit Tarcsa
4 AbbVie;
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Antoine Deslandes
5 Sanofi;
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Ramaswamy A Iyer
6 BMS;
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Amita Datta-Mannan
7 Eli Lilly;
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Priya Sriraman
8 Celegene;
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Michaela Bairlein
9 Bayer;
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Johnny J Yang
10 Takeda;
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Matthew Barfield
11 GSK;
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Guangqing Xiao
12 Biogen Idec;
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Enrique Escandon
13 Merck;
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Weirong Wang
14 Janssen;
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Dan A Rock
15 Amgen;
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Nagendra V Chemuturi
16 Seattle Genetics;
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David J Moore
17 Roche
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Abstract

An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a highly potent drug molecule conjugated to a monoclonal antibody (mAb). As the number of ADCs in various stages of nonclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches to understanding the disposition of ADCs. In order to identify the key ADME issues worth examining when developing an ADC and to find optimal scientifically-based approaches to evaluate ADC ADME, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an "ADC ADME working group" in early 2014. This White Paper contains observations from the working group and provides an initial framework on issues and approaches to consider when evaluating the ADME of ADCs.

  • anticancer agents
  • biologics/therapeutic proteins
  • drug-drug interactions
  • pharmacokinetics
  • The American Society for Pharmacology and Experimental Therapeutics
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Drug Metabolism and Disposition: 50 (5)
Drug Metabolism and Disposition
Vol. 50, Issue 5
1 May 2022
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Research ArticleMinireview

Current Approaches for ADME Characterization of Antibody-Drug Conjugates: An Industry White Paper

Eugenia Kraynov, Amrita V Kamath, Markus Walles, Edit Tarcsa, Antoine Deslandes, Ramaswamy A Iyer, Amita Datta-Mannan, Priya Sriraman, Michaela Bairlein, Johnny J Yang, Matthew Barfield, Guangqing Xiao, Enrique Escandon, Weirong Wang, Dan A Rock, Nagendra V Chemuturi and David J Moore
Drug Metabolism and Disposition December 15, 2015, dmd.115.068049; DOI: https://doi.org/10.1124/dmd.115.068049

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Research ArticleMinireview

Current Approaches for ADME Characterization of Antibody-Drug Conjugates: An Industry White Paper

Eugenia Kraynov, Amrita V Kamath, Markus Walles, Edit Tarcsa, Antoine Deslandes, Ramaswamy A Iyer, Amita Datta-Mannan, Priya Sriraman, Michaela Bairlein, Johnny J Yang, Matthew Barfield, Guangqing Xiao, Enrique Escandon, Weirong Wang, Dan A Rock, Nagendra V Chemuturi and David J Moore
Drug Metabolism and Disposition December 15, 2015, dmd.115.068049; DOI: https://doi.org/10.1124/dmd.115.068049
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