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The value, qualification, and regulatory use of surrogate end points in drug development.
Lathia CD, Amakye D, Dai W, Girman C, Madani S, Mayne J, MacCarthy P, Pertel P, Seman L, Stoch A, Tarantino P, Webster C, Williams S, Wagner JA. Lathia CD, et al. Among authors: wagner ja. Clin Pharmacol Ther. 2009 Jul;86(1):32-43. doi: 10.1038/clpt.2009.69. Epub 2009 May 27. Clin Pharmacol Ther. 2009. PMID: 19474783 Review.
Rifampin's acute inhibitory and chronic inductive drug interactions: experimental and model-based approaches to drug-drug interaction trial design.
Reitman ML, Chu X, Cai X, Yabut J, Venkatasubramanian R, Zajic S, Stone JA, Ding Y, Witter R, Gibson C, Roupe K, Evers R, Wagner JA, Stoch A. Reitman ML, et al. Among authors: wagner ja. Clin Pharmacol Ther. 2011 Feb;89(2):234-42. doi: 10.1038/clpt.2010.271. Epub 2010 Dec 29. Clin Pharmacol Ther. 2011. PMID: 21191377
Multiple-dose pharmacokinetics, pharmacodynamics, and safety of taranabant, a novel selective cannabinoid-1 receptor inverse agonist, in healthy male volunteers.
Addy C, Rothenberg P, Li S, Majumdar A, Agrawal N, Li H, Zhong L, Yuan J, Maes A, Dunbar S, Cote J, Rosko K, Van Dyck K, De Lepeleire I, de Hoon J, Van Hecken A, Depré M, Knops A, Gottesdiener K, Stoch A, Wagner J. Addy C, et al. J Clin Pharmacol. 2008 Jun;48(6):734-44. doi: 10.1177/0091270008317591. J Clin Pharmacol. 2008. PMID: 18508950 Clinical Trial.
Safety, tolerability, pharmacokinetics, and pharmacodynamic properties of taranabant, a novel selective cannabinoid-1 receptor inverse agonist, for the treatment of obesity: results from a double-blind, placebo-controlled, single oral dose study in healthy volunteers.
Addy C, Li S, Agrawal N, Stone J, Majumdar A, Zhong L, Li H, Yuan J, Maes A, Rothenberg P, Cote J, Rosko K, Cummings C, Warrington S, Boyce M, Gottesdiener K, Stoch A, Wagner J. Addy C, et al. J Clin Pharmacol. 2008 Apr;48(4):418-27. doi: 10.1177/0091270008314467. Epub 2008 Feb 7. J Clin Pharmacol. 2008. PMID: 18258750 Clinical Trial.
Measuring Biomarker Progress.
Wagner JA, Atkinson AJ Jr. Wagner JA, et al. Clin Pharmacol Ther. 2015 Jul;98(1):2-5. doi: 10.1002/cpt.133. Clin Pharmacol Ther. 2015. PMID: 25870036
554 results