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Industry Perspective on Contemporary Protein-Binding Methodologies: Considerations for Regulatory Drug-Drug Interaction and Related Guidelines on Highly Bound Drugs.
Di L, Breen C, Chambers R, Eckley ST, Fricke R, Ghosh A, Harradine P, Kalvass JC, Ho S, Lee CA, Marathe P, Perkins EJ, Qian M, Tse S, Yan Z, Zamek-Gliszczynski MJ. Di L, et al. J Pharm Sci. 2017 Dec;106(12):3442-3452. doi: 10.1016/j.xphs.2017.09.005. Epub 2017 Sep 18. J Pharm Sci. 2017. PMID: 28927987 Review.
Validation of 96-well equilibrium dialysis with non-radiolabeled drug for definitive measurement of protein binding and application to clinical development of highly-bound drugs.
Zamek-Gliszczynski MJ, Ruterbories KJ, Ajamie RT, Wickremsinhe ER, Pothuri L, Rao MV, Basavanakatti VN, Pinjari J, Ramanathan VK, Chaudhary AK. Zamek-Gliszczynski MJ, et al. J Pharm Sci. 2011 Jun;100(6):2498-507. doi: 10.1002/jps.22452. Epub 2011 Jan 6. J Pharm Sci. 2011. PMID: 21213309
ITC recommendations for transporter kinetic parameter estimation and translational modeling of transport-mediated PK and DDIs in humans.
Zamek-Gliszczynski MJ, Lee CA, Poirier A, Bentz J, Chu X, Ellens H, Ishikawa T, Jamei M, Kalvass JC, Nagar S, Pang KS, Korzekwa K, Swaan PW, Taub ME, Zhao P, Galetin A; International Transporter Consortium. Zamek-Gliszczynski MJ, et al. Clin Pharmacol Ther. 2013 Jul;94(1):64-79. doi: 10.1038/clpt.2013.45. Epub 2013 Feb 25. Clin Pharmacol Ther. 2013. PMID: 23588311 Free PMC article. Review.
Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design.
Lee CA, O'Connor MA, Ritchie TK, Galetin A, Cook JA, Ragueneau-Majlessi I, Ellens H, Feng B, Taub ME, Paine MF, Polli JW, Ware JA, Zamek-Gliszczynski MJ. Lee CA, et al. Drug Metab Dispos. 2015 Apr;43(4):490-509. doi: 10.1124/dmd.114.062174. Epub 2015 Jan 13. Drug Metab Dispos. 2015. PMID: 25587128 Review.
67 results