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Considerations for Human ADME Strategy and Design Paradigm Shift(s) – An Industry White Paper
Author(s) -
Young Graeme C.,
Spracklin Douglas K.,
James Alexander D.,
Hvenegaard Mette G.,
Scarfe Graeme,
Wagner David S.,
Georgi Katrin,
Schieferstein Hanno,
Bjornsdottir Inga,
Groen Bianca,
Romeo Andrea A.,
Cassidy Kenneth C.,
Daviolante Georges,
Bister Bojan,
Blech Stefan,
Lyer Ramaswamy,
Schulz Simone I.,
Cuyckens Filip,
Moliner Patricia
Publication year - 2023
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2691
Subject(s) - adme , paradigm shift , cornerstone , flexibility (engineering) , risk analysis (engineering) , variety (cybernetics) , drug , pharmaceutical industry , distribution (mathematics) , disposition , computer science , business , pharmacology , engineering ethics , medicine , engineering , psychology , economics , management , artificial intelligence , mathematics , epistemology , art , mathematical analysis , social psychology , philosophy , visual arts
The human absorption, distribution, metabolism, and excretion (hADME) study is the cornerstone of the clinical pharmacology package for small molecule drugs, providing comprehensive information on the rates and routes of disposition and elimination of drug‐related material in humans through the use of 14 C‐labeled drug. Significant changes have already been made in the design of the hADME study for many companies, but opportunity exists to continue to re‐think both the design and timing of the hADME study in light of the potential offered by newer technologies, that enable flexibility in particular to reducing the magnitude of the radioactive dose used. This paper provides considerations on the variety of current strategies that exist across a number of pharmaceutical companies and on some of the ongoing debates around a potential move to the so called “human first/human only” approach, already adopted by at least one company. The paper also provides a framework for continuing the discussion in the application of further shifts in the paradigm.