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"Cocktail" approaches and strategies in drug development: valuable tool or flawed science?
Zhou H, Tong Z, McLeod JF. Zhou H, et al. Among authors: mcleod jf. J Clin Pharmacol. 2004 Feb;44(2):120-34. doi: 10.1177/0091270003261333. J Clin Pharmacol. 2004. PMID: 14747420 Review.
PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications.
Karara AH, Edeki T, McLeod J, Tonelli AP, Wagner JA. Karara AH, et al. J Clin Pharmacol. 2010 Apr;50(4):380-91. doi: 10.1177/0091270009344987. Epub 2010 Jan 23. J Clin Pharmacol. 2010. PMID: 20097935
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. 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. Drug Metab Dispos. 2003 Jul;31(7):815-32. doi: 10.1124/dmd.31.7.815. Drug Metab Dispos. 2003. PMID: 12814957
Pharmacokinetics of nateglinide in renally impaired diabetic patients.
Devineni D, Walter YH, Smith HT, Lee JS, Prasad P, McLeod JF. Devineni D, et al. Among authors: mcleod jf. J Clin Pharmacol. 2003 Feb;43(2):163-70. doi: 10.1177/0091270002239825. J Clin Pharmacol. 2003. PMID: 12616669 Clinical Trial.
Tegaserod coadministration does not alter the pharmacokinetics of theophylline in healthy subjects.
Zhou H, Khalilieh S, Svendsen K, Pommier F, Osborne S, Appel-Dingemanse S, Lasseter K, McLeod JF. Zhou H, et al. Among authors: mcleod jf. J Clin Pharmacol. 2001 Sep;41(9):987-93. doi: 10.1177/00912700122010979. J Clin Pharmacol. 2001. PMID: 11549104 Clinical Trial.
Population PK and PK/PD modelling of microencapsulated octreotide acetate in healthy subjects.
Zhou H, Chen TL, Marino M, Lau H, Miller T, Kalafsky G, McLeod JF. Zhou H, et al. Among authors: mcleod jf. Br J Clin Pharmacol. 2000 Dec;50(6):543-52. doi: 10.1046/j.1365-2125.2000.00297.x. Br J Clin Pharmacol. 2000. PMID: 11136293 Free PMC article. Clinical Trial.
The effects of tegaserod (HTF 919) on the pharmacokinetics and pharmacodynamics of digoxin in healthy subjects.
Zhou H, Horowitz A, Ledford PC, Hubert M, Appel-Dingemanse S, Osborne S, McLeod JF. Zhou H, et al. Among authors: mcleod jf. J Clin Pharmacol. 2001 Oct;41(10):1131-9. doi: 10.1177/00912700122012625. J Clin Pharmacol. 2001. PMID: 11583482 Clinical Trial.
Mealtime glucose regulation by nateglinide in type-2 diabetes mellitus.
Walter YH, Spratt DI, Garreffa S, McLeod JF. Walter YH, et al. Among authors: mcleod jf. Eur J Clin Pharmacol. 2000 May;56(2):129-33. doi: 10.1007/s002280050730. Eur J Clin Pharmacol. 2000. PMID: 10877006 Clinical Trial.
Effect of a selective CYP2C9 inhibitor on the pharmacokinetics of nateglinide in healthy subjects.
Sabia H, Sunkara G, Ligueros-Saylan M, Wang Y, Smith H, McLeod J, Prasad P. Sabia H, et al. Eur J Clin Pharmacol. 2004 Aug;60(6):407-12. doi: 10.1007/s00228-004-0778-4. Epub 2004 Jun 9. Eur J Clin Pharmacol. 2004. PMID: 15197517 Clinical Trial.
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