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Alexander D James

Explore the profile of Alexander D James including associated specialties, affiliations and a list of published articles. Areas
Snapshot
Articles 7
Citations 61
Followers 0
Related Specialties
Pharmacology
Chemistry
Top 10 Co-Authors
Douglas K Spracklin
Mette G Hvenegaard
Inga Bjornsdottir
Hanno Schieferstein
Andrea A Romeo
Kenneth C Cassidy
Graeme C Young
Katrin Georgi
Simone I Schulz
Stefan Blech
Published In
Drug Metab Dispos
Clin Pharmacol Ther
Pharmacol Res Perspect
J Am Chem Soc
Affiliations
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Recent Articles
1.
Cross-industry demonstration of the validity of the mixed matrix method for the assessment of cross-species exposure coverage of human circulating drug metabolites
James A, Lanshoeft C, Steeno G, Spracklin D, You Z, Sharma R, et al.
Drug Metab Dispos . 2025 Mar; 53(3):100041. PMID: 40048992
The mixed matrix method (MmM) is a widely used approach by the pharmaceutical industry for early assessment of whether exposures to major human circulating metabolites, of traditional small-molecule drugs, are...
2.
Recommendations on the Use of Multiple Labels in Human Mass Balance Studies
Cuyckens F, Hvenegaard M, Cassidy K, Spracklin D, James A, Pedersen M, et al.
Drug Metab Dispos . 2024 Jan; 52(3):153-158. PMID: 38216306
The administration of radiolabeled drug candidates is considered the gold standard in absorption, distribution, metabolism, and excretion studies for small-molecule drugs since it allows facile and accurate quantification of parent...
3.
Non-Labeled, Stable Labeled, or Radiolabelled Approaches for Provision of Intravenous Pharmacokinetics in Humans: A Discussion Piece
Young G, Spracklin D, James A, Hvenegaard M, Pedersen M, Wagner D, et al.
Clin Pharmacol Ther . 2023 Nov; 115(5):931-938. PMID: 38018358
A review of the use of microdoses and isotopic microtracers for clinical intravenous pharmacokinetic (i.v. PK) data provision is presented. The extent of application of the varied approaches available and...
4.
Considerations for Human ADME Strategy and Design Paradigm Shift(s) - An Industry White Paper
Young G, Spracklin D, James A, Hvenegaard M, Scarfe G, Wagner D, et al.
Clin Pharmacol Ther . 2022 Jun; 113(4):775-781. PMID: 35733280
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...
5.
Insights into the Chemistry of Iodine New Particle Formation: The Role of Iodine Oxides and the Source of Iodic Acid
Martin J, Lewis T, James A, Saiz-Lopez A, Plane J
J Am Chem Soc . 2022 May; 144(21):9240-9253. PMID: 35604404
Iodine chemistry is an important driver of new particle formation in the marine and polar boundary layers. There are, however, conflicting views about how iodine gas-to-particle conversion proceeds. Laboratory studies...
6.
An integrated assessment of the ADME properties of the CDK4/6 Inhibitor ribociclib utilizing preclinical in vitro, in vivo, and human ADME data
James A, Schiller H, Marvalin C, Jin Y, Borell H, Roffel A, et al.
Pharmacol Res Perspect . 2020 Jun; 8(3):e00599. PMID: 32524755
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...
7.
Metabolism and Disposition of Siponimod, a Novel Selective S1P/S1P Agonist, in Healthy Volunteers and In Vitro Identification of Human Cytochrome P450 Enzymes Involved in Its Oxidative Metabolism
Glaenzel U, Jin Y, Nufer R, Li W, Schroer K, Adam-Stitah S, et al.
Drug Metab Dispos . 2018 May; 46(7):1001-1013. PMID: 29735753
Siponimod, a next-generation selective sphingosine-1-phosphate receptor modulator, is currently being investigated for the treatment of secondary progressive multiple sclerosis. We investigated the absorption, distribution, metabolism, and excretion (ADME) of a...
8.
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 S, Funk C, Hop C, Humphreys W, et al.
Drug Metab Dispos . 2018 Mar; 46(6):865-878. PMID: 29487142
Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and...