Affiliation: AstraZeneca R and D
- Validation and application of Caco-2 assays for the in vitro evaluation of development candidate drugs as substrates or inhibitors of P-glycoprotein to support regulatory submissionsR Elsby
Development Drug Metabolism and Pharmacokinetics and Bioanalysis Charnwood, Loughborough, UK
Xenobiotica 38:1140-64. 2008..They have been successfully applied to development projects resulting in the identification of two candidate drugs as substrates and inhibitors of P-gp, whereas a third was neither a substrate nor an inhibitor of this transporter...
- The utility of in vitro data in making accurate predictions of human P-glycoprotein-mediated drug-drug interactions: a case study for AZD5672Robert Elsby
Clinical Pharmacology and DMPK, AstraZeneca R and D Charnwood, Bakewell Road, Loughborough, Leicestershire, LE11 5RH, UK
Drug Metab Dispos 39:275-82. 2011..The observed dose-dependent clinically significant interaction was accurately predicted using calculated [I(2)] and in vitro P-gp inhibition data, confirming AZD5672 to be a P-gp inhibitor in vivo...
- Understanding the critical disposition pathways of statins to assess drug-drug interaction risk during drug development: it's not just about OATP1B1R Elsby
Global DMPK In Vitro In Silico ADME, AstraZeneca R and D Alderley Park, Cheshire, UK
Clin Pharmacol Ther 92:584-98. 2012..Finally, on a statin-by-statin basis, we propose in vitro inhibition studies that should be routinely conducted during drug development so as to better assess DDI risk...
- In vitro risk assessment of AZD9056 perpetrating a transporter-mediated drug-drug interaction with methotrexateRobert Elsby
Clinical Pharmacology and DMPK, AstraZeneca Research and Development Charnwood, Loughborough, Leicestershire, United Kingdom
Eur J Pharm Sci 43:41-9. 2011....
- Validation of membrane vesicle-based breast cancer resistance protein and multidrug resistance protein 2 assays to assess drug transport and the potential for drug-drug interaction to support regulatory submissionsRobert Elsby
Clinical Pharmacology and DMPK, AstraZeneca R and D Charnwood, Loughborough, Leicestershire, UK
Xenobiotica 41:764-83. 2011..The approach builds on earlier validations to support drug registration and extends from those cell-based systems to encompass assay formats using membrane vesicles...
- Validation of cell-based OATP1B1 assays to assess drug transport and the potential for drug-drug interaction to support regulatory submissionsP Sharma
Clinical Pharmacology and DMPK, AstraZeneca R and D Charnwood, Loughborough LE11 5RH, UK
Xenobiotica 40:24-37. 2010..These validated OATP1B1 assays were robust, reproducible, and suitable for routine in vitro evaluation of candidate drugs...