Considerations for Human ADME Strategy and Design Paradigm Shift(s) – An Industry White Paper
A schematic of the generalised current process and a proposed shift in paradigm to Human First/Human Only

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

Significant changes have already been made in the design of the hADME study (for many companies), but the 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.?It is hoped that this article will form the framework for continuing to discuss and share the benefits in application of further shifts in the paradigm. Douglas Spracklin , Alex James , Mette Graulund Hvenegaard , Graeme Scarfe , David Wagner ' Katrin Georgi , Hanno Schieferstein , Inga Bj?rnsdottir , Bianca van Groen , Andrea A. Romeo , Ken Cassidy , Georges Da violante , Bojan Bister , Stefan Blech , Ramaswamy Iyer , Filip Cuyckens , Patricia Moliner

Silvia Martinucci

Senior Scientist at Lundbeck

2 年

Congratulations to all the authors! A Good team work ??!

Steven Erpelinck, MBA

CCO/co-founder of Peregrion | Principal Business Developer TNO Efficient Drug Development. Curious learning more about your Preclinical/Clinical DMPK/ADME challenges

2 年

Hi Graeme, your Industry White Paper is a must read if you are involved in #ADME studies. See you at the #ISSX in Seattle next week.

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