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The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective.
Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach SR, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America Drug Metabolism/Clinical Pharmacology Technical Working Groups. Bjornsson TD, et al. Among authors: fischer v. J Clin Pharmacol. 2003 May;43(5):443-69. J Clin Pharmacol. 2003. PMID: 12751267 Review.
The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective.
Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach RS, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism/Clinical Pharmacology Technical Working Group; FDA Center for Drug Evaluation and Research (CDER). Bjornsson TD, et al. Among authors: fischer v. Drug Metab Dispos. 2003 Jul;31(7):815-32. doi: 10.1124/dmd.31.7.815. Drug Metab Dispos. 2003. PMID: 12814957
Efflux transporters and their clinical relevance.
Fischer V, Einolf HJ, Cohen D. Fischer V, et al. Mini Rev Med Chem. 2005 Feb;5(2):183-95. doi: 10.2174/1389557053402756. Mini Rev Med Chem. 2005. PMID: 15720288 Review.
Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug.
Vieira ML, Kirby B, Ragueneau-Majlessi I, Galetin A, Chien JY, Einolf HJ, Fahmi OA, Fischer V, Fretland A, Grime K, Hall SD, Higgs R, Plowchalk D, Riley R, Seibert E, Skordos K, Snoeys J, Venkatakrishnan K, Waterhouse T, Obach RS, Berglund EG, Zhang L, Zhao P, Reynolds KS, Huang SM. Vieira ML, et al. Among authors: fischer v. Clin Pharmacol Ther. 2014 Feb;95(2):189-98. doi: 10.1038/clpt.2013.187. Epub 2013 Sep 18. Clin Pharmacol Ther. 2014. PMID: 24048277
PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 1: goals, properties of the PhRMA dataset, and comparison with literature datasets.
Poulin P, Jones HM, Jones RD, Yates JW, Gibson CR, Chien JY, Ring BJ, Adkison KK, He H, Vuppugalla R, Marathe P, Fischer V, Dutta S, Sinha VK, Björnsson T, Lavé T, Ku MS. Poulin P, et al. Among authors: fischer v. J Pharm Sci. 2011 Oct;100(10):4050-73. doi: 10.1002/jps.22554. Epub 2011 Apr 26. J Pharm Sci. 2011. PMID: 21523782
PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: prediction of plasma concentration-time profiles in human by using the physiologically-based pharmacokinetic modeling approach.
Poulin P, Jones RD, Jones HM, Gibson CR, Rowland M, Chien JY, Ring BJ, Adkison KK, Ku MS, He H, Vuppugalla R, Marathe P, Fischer V, Dutta S, Sinha VK, Björnsson T, Lavé T, Yates JW. Poulin P, et al. Among authors: fischer v. J Pharm Sci. 2011 Oct;100(10):4127-57. doi: 10.1002/jps.22550. Epub 2011 May 3. J Pharm Sci. 2011. PMID: 21541937
PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: comparative assessement of prediction methods of human clearance.
Ring BJ, Chien JY, Adkison KK, Jones HM, Rowland M, Jones RD, Yates JW, Ku MS, Gibson CR, He H, Vuppugalla R, Marathe P, Fischer V, Dutta S, Sinha VK, Björnsson T, Lavé T, Poulin P. Ring BJ, et al. Among authors: fischer v. J Pharm Sci. 2011 Oct;100(10):4090-110. doi: 10.1002/jps.22552. Epub 2011 May 3. J Pharm Sci. 2011. PMID: 21541938
PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 4: prediction of plasma concentration-time profiles in human from in vivo preclinical data by using the Wajima approach.
Vuppugalla R, Marathe P, He H, Jones RD, Yates JW, Jones HM, Gibson CR, Chien JY, Ring BJ, Adkison KK, Ku MS, Fischer V, Dutta S, Sinha VK, Björnsson T, Lavé T, Poulin P. Vuppugalla R, et al. Among authors: fischer v. J Pharm Sci. 2011 Oct;100(10):4111-26. doi: 10.1002/jps.22551. Epub 2011 Apr 7. J Pharm Sci. 2011. PMID: 21480234
PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 2: comparative assessment of prediction methods of human volume of distribution.
Jones RD, Jones HM, Rowland M, Gibson CR, Yates JW, Chien JY, Ring BJ, Adkison KK, Ku MS, He H, Vuppugalla R, Marathe P, Fischer V, Dutta S, Sinha VK, Björnsson T, Lavé T, Poulin P. Jones RD, et al. Among authors: fischer v. J Pharm Sci. 2011 Oct;100(10):4074-89. doi: 10.1002/jps.22553. Epub 2011 Mar 30. J Pharm Sci. 2011. PMID: 21452299
393 results