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Page 1
A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.
Schadt S, Bister B, Chowdhury SK, Funk C, Hop CECA, Humphreys WG, Igarashi F, James AD, Kagan M, Khojasteh SC, Nedderman ANR, Prakash C, Runge F, Scheible H, Spracklin DK, Swart P, Tse S, Yuan J, Obach RS. Schadt S, et al. Among authors: bister b. Drug Metab Dispos. 2018 Jun;46(6):865-878. doi: 10.1124/dmd.117.079848. Epub 2018 Feb 27. Drug Metab Dispos. 2018. PMID: 29487142 Review.
Considerations for Human ADME Strategy and Design Paradigm Shift(s) - An Industry White Paper.
Young GC, Spracklin DK, James AD, Hvenegaard MG, Scarfe G, Wagner DS, Georgi K, Schieferstein H, Bjornsdottir I, van Groen B, Romeo AA, Cassidy KC, Da-Violante G, Bister B, Blech S, Lyer R, Schulz SI, Cuyckens F, Moliner P. Young GC, et al. Among authors: bister b. Clin Pharmacol Ther. 2023 Apr;113(4):775-781. doi: 10.1002/cpt.2691. Epub 2022 Sep 2. Clin Pharmacol Ther. 2023. PMID: 35733280
22 results