Differences in metabolic elimination can be observed when drugs are taken with food or co-administered with other drugs. These differences can be significant, and can result in increases or decreases in drug exposure that may have an impact on the efficacy or safety profile of a therapeutic. For example, metabolic routes of elimination that involve cytochrome P450 enzymes can be dramatically altered by concomitant drug treatments that inhibit or induce P450 enzymes. One specific objective of food and alcohol effect studies and metabolic drug-drug interaction studies is to identify the circumstances under which dosage adjustments, safety monitoring, or safety labeling may be needed.
Clinilabs provides a modern facility for food, alcohol, and drug interaction studies that enables sponsors to complete work promptly and with confidence. Standardized protocols enable sponsors to identify a multiplicity of effects, including drug group differences based on age, race, gender, or other subject characteristics.
|
