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Alexander David James
Researcher at Novartis
Publications - 8
Citations - 166
Alexander David James is an academic researcher from Novartis. The author has contributed to research in topics: Metabolite & ADME. The author has an hindex of 5, co-authored 6 publications receiving 98 citations.
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Journal ArticleDOI
A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance
Simone Schadt,Bojan Bister,Swapan Chowdhury,Christoph Funk,Cornelis E. C. A. Hop,W. Griffith Humphreys,Fumihiko Igarashi,Alexander David James,Mark Kagan,S. Cyrus Khojasteh,Angus N. R. Nedderman,Chandra Prakash,Frank Runge,Holger Scheible,Douglas K. Spracklin,Piet Swart,Susanna Tse,Josh Yuan,R. Scott Obach +18 more
TL;DR: How the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolite profiles is discussed.
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Metabolism and Disposition of Siponimod, a Novel Selective S1P1/S1P5 Agonist, in Healthy Volunteers and In Vitro Identification of Human Cytochrome P450 Enzymes Involved in Its Oxidative Metabolism.
Ulrike Glaenzel,Yi Jin,Robert Nufer,Wenkui Li,Kirsten Schroer,Sylvie Adam-Stitah,Sjoerd Peter van Marle,Eric Legangneux,Hubert Borell,Alexander David James,Axel Meissner,Gian Camenisch,Anne Gardin +12 more
TL;DR: The selective inhibitor and recombinant enzyme results identified cytochrome P450 2C9 (CYP2C9) as the predominant contributor to the human liver microsomal biotransformation of siponimod, with minor contributions from CYP3A4 and other cyto Chrome P450 enzymes.
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Absorption, distribution, metabolism, and excretion of [(14)C]BYL719 (alpelisib) in healthy male volunteers.
Alexander David James,Lars Blumenstein,Ulrike Glaenzel,Yi Jin,Arnold Demailly,Annamaria Jakab,Regine Hansen,Katharine Hazell,Anuradha Mehta,Lucia Trandafir,Piet Swart +10 more
TL;DR: Alpelisib was rapidly absorbed and cleared by multiple metabolic pathways; the primary metabolite M4 is pharmacologically inactive and is therefore a promising candidate for combination therapy.
Journal ArticleDOI
Comparison of 19F NMR and 14C Measurements for the Assessment of ADME of BYL719 (Alpelisib) in Humans
TL;DR: The capabilities of 19F nuclear magnetic resonance (NMR) spectroscopy, applied as an alternative to radiolabeling, for the determination of mass balance and for metabolite profiling of an orally administered fluorinated drug are demonstrated.
Journal ArticleDOI
An integrated assessment of the ADME properties of the CDK4/6 Inhibitor ribociclib utilizing preclinical in vitro, in vivo, and human ADME data
Alexander David James,Hilmar Schiller,Cyrille Marvalin,Yi Jin,Hubert Borell,Ad Roffel,Ulrike Glaenzel,Yan Ji,Gian Camenisch +8 more
TL;DR: Ribociclib (LEE011, Kisqali ®) is a highly selective small molecule inhibitor of cyclin‐dependent kinases 4 and 6 (CDK4/6), which has been approved for the treatment of advanced or metastatic breast cancer.