Considerations for Human ADME Strategy and Design Paradigm Shift(s) – An Industry White Paper

• DOI: 10.1002/cpt.2691
• Publication Date: 2022-06-23T04:07:56Z
• Authors: Graeme C. Young; Douglas K. Spracklin; Alexander D. James; Mette G. Hvenegaard; Graeme Scarfe; David S. Wagner; Katrin Georgi; Hanno Schieferstein; Inga Bjornsdottir; Bianca van Groen; Andrea A. Romeo; Kenneth C. Cassidy; Georges Da‐violante; Bojan Bister; Stefan Blech; Ramaswamy Lyer; Simone I. Schulz; Filip Cuyckens; Patricia Moliner
• Keywords: ADME; Paradigm shift; Cornerstone; Disposition

The human absorption, distribution, metabolism, and excretion (hADME) study is the cornerstone of clinical pharmacology package for small molecule drugs, providing comprehensive information on rates routes disposition elimination drug-related material in humans through use