Evaluations of Drug Interactions

Drug interactions resources (e.g.. Drug Interaction Facts, Drug Interactions Analysis and Management, Evaluation of Drug Interactions)... 

First DataBank s Evaluations of Drug Interactions (EDI) provides the most comprehensive printed source of drug-drug interaction information available. Containing interactions on both prescription and over-the-counter drugs, this two-volume loose-leaf textbook of drug monographs is the only source endorsed by the American Pharmaceutical Association. 

Hochman JH, Yamazaki M, Ohe T, Ein JH. Evaluation of drug interactions with P-glycoprotein in drug discovery in vitro assessment of the potential for drug-drug interactions with P-glycoprotein. Curr Drug Metab 2002 3(3) 257-273. 

The APhA efforts culminated in a consensus document in 1971 called Evaluations of Drug Interactions, the intent of which was to offer sufficient information to allow physicians and pharmacists to make authoritative judgments concerning specific drug interactions. This effort paved the way for the collection of DDI information into commercial electronic data bases. 

Zucchero F et al. (2004). Pocket Guide to Evaluation of Drug Interactions. 5th edn. Washington, DC American Pharmacists Association. 

Vanhoefer U, Schleucher N, Klaassen U, Seeber S, Harstrick A. Ifosfamide-based drug combinations preclinical evaluation of drug interactions and translation into the clinic. Semin Oncol (2000) 27 (Suppl 1), 8-13. 

Gallo JM, Swagler AR, Mehta M, Qian M. Pharmacokinetic evaluation of drug interactions with anti-human immunodeficiency virus drugs. VI. Effect of the calcium channel blocker nimodipine on zidovudine kinetics inmonkeys. JPharmacolExp Ther( 993) 264,315-20. 

Cockbum I. Cyclosporine A a clinical evaluation of drug interactions. Transplant Proc (1986) 18 (Suppl 5), 50-5. 

Shitara Y, Sato H, Sugiyama Y (2005) Evaluation of drug-drug interactions in the hepatobiliary and renal transport of drugs. Annu Rev Pharmacol Toxicol 45 689-723... 

Shapiro, D and Oakley, M., Methodological issues in the evaluation of drug behavioral interactions in the treatment of hypertension. Psychosomatic Medicine 51(3), 269-276, 1989. 

For in vivo studies, animal models are set up and how the target is involved in the disease is analyzed. One such model is the use of knockout or transgenic mice (Exhibit 2.8). It should be borne in mind, however, that there are differences between humans and animals in terms of gene expression, functional characteristics, and biochemical reactions. Nevertheless, animal models are important for the evaluation of drug-target interactions in a living system. 

Table 2A Labeling Examples of Drug-Drug Interactions (Evaluation of Drugs as Substrates for CYP Enzymes)...

Food and Drug Administration Advisory Committee for pharmaceutical sciences and Clinical Pharmacology Subcommittee meeting. Issues and challenges in the evaluation and labeling of drug interaction potentials of NME. Rockville, MD, April 23, 2003 http //www.fda.gov/ohrms/dockets/ac/03/ slides/3947s2.htm http //www.fda.gov/ohrms/dockets/ac/03/transcripts /... 

Information in the PI is typically based on the studies submitted by a drug s manufacturer. The FDA has also utilized spontaneous adverse event case reports as a tool in the evaluation of drug-grapefruit juice interaction labeling. Other sources of data that contribute to labeled information include studies or case reports from the medical literature. 

Halmos, T., et al. 1997. Synthesis of O-methylsulfonyl derivatives of D-glucose as potential alkylating agents for targeted drug delivery to the brain. Evaluation of their interaction with the human erythrocyte GLUT1 hexose transporter. Carbohydr Res 299 15. 

Guidance on the Investigation of Drug Interactions. Committee for Proprietary Medicinal Products. The European Agency for the Evaluation of Medicinal Products. Human Medicines Evaluation Unit. December 1997. Available at http //www.emea. eu.int. Accessed October 2006. 

Riley, R. J., Kenna, J. G. Cellular models for ADMET predictions and evaluation of drug-drug interactions. Curr. Opin. Drug Discov. Dev. 2004, 7 86-89. 

Li AP (1997) Evaluation of drug-drug interactions in primary human hepatocytes. In Li AP (ed) Drug-drug Interactions Scientific and Regulatory Perspectives. Advances in Pharmacology 43 103-130... 

Li AP, Maurel JP, Lechon-Gomez M et al. (1997) Preclinical evaluation of drug-drug interactions present status of the application of primary human hepatocytes in the evaluation of cytochrome P450 induction. Chemico-Biological Interactions 107 5-16... 

Li AP, Reith MK, Rasmussen A et al. (1997) In vitro evaluation of drug-drug interaction potential A comparison of rifampin, rifapentine, and rifabutin in cytochrome P450 3A induction potential in primary human hepatocytes. Chemico-Biological Interactions 107 17-30... 

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