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Assessment of the Current Approaches for ADME Characterization of Antibody-Drug Conjugates and Recommendations for Best Practices: An Industry White Paper

Kraynov, Eugenia and Kamath, Amrita and Walles, Markus and Tarcsa, edit and Deslandes, Antoine and Datta, Amita and Siraman, Priya and Bairlein, Michaela and Yang, Johnny and Barfield, Matthew and Xiao, Guangchin and Escandon , Enrique and Wang, Weiron and Rock, Dan and Moore, David (2016) Assessment of the Current Approaches for ADME Characterization of Antibody-Drug Conjugates and Recommendations for Best Practices: An Industry White Paper. Drug Metabolism and Disposition.

Abstract

An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a drug molecule covalently conjugated to a carrier monoclonal antibody (mAb). As the number of ADCs in various stages of preclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches for ADC ADME characterization. In order to seek alignment on the strategy and find the most optimal experimental systems, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an “ADC ADME working group” in early 2014. This White Paper contains observations and recommendations from the working group.

Item Type: Article
Keywords: Antibody drug conjugates, ADME, White paper
Date Deposited: 26 Apr 2016 23:45
Last Modified: 26 Apr 2016 23:45
URI: https://oak.novartis.com/id/eprint/26299

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