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An example of this is evident in the labeling for ZYFLO CR® tablets, which contain zileuton as the active ingredient. A number of drug interaction studies were performed (theophylline, warfarin, propranolol, prednisone, ethinyl estradiol, digoxin, phenytoin, sulfasalazine, and naproxen), with clinically significant interactions noted for theophylline, propranolol, and warfarin. The increase in theophylline and propranolol AUC was approximately twofold, while the increase in R-warfarin AUC was about 22%.

Based on preclinical data, rational clinical plans can be developed to study potential drug–drug interactions in humans and develop labeling that allows optimal usage of new drugs. 1 Introduction Adverse drug reactions are a major public health concern. It has been estimated that approximately 5% of hospital admissions are related to adverse drug reactions (Kongkaew et al. 2008), although other estimates have placed this value between 3% and 28% (McDonnell and Jacobs 2002). Hospital admissions for adverse drug reactions are highest in elderly subjects who are taking multiple medications (Kongkaew et al.

Sanga S, Sinek JP, Frieboes HB, Ferrari M, Fruehauf JP and Cristini V (2006) Mathematical modeling of cancer progression and response to chemotherapy. Expert Review of Anticancer Therapy 6:1361–1765. Schwartz LH, Ginsberg MS, DeCorato D, Rothenberg LN, Einstein S, Kijewski P and Panicek DM (2000) Evaluation of tumor measurements in oncology: use of file based and electronic techniques. Journal of Clinical Oncology 18:2179–2184. Sharpless NE and DePinho RA (2006) The mighty mouse: genetically engineered mouse models in cancer drug development.

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