衔接性试验评价与要动学之应用.pptVIP

Japan US/EU Dose 2.5 mg/d 5 mg/d AUC0-24hr (ng.hr/mL) 2.90 ? 1.54 2.52 ? 1.23 Bone mineral density √ √ Risedronate Na Differences in Pharmacokinetics Others include: Alendronate Na Omeprazole + clarithromycin + amoxicillin Clinical pharmacology therapeutics; 2005:78(2)102-13 Pharmacokinetic differences May not always create that necessity : dosage adjustments in some cases might be made without new trials.  However any substantial difference in metabolic pattern : may often indicate a need for a controlled clinical trial. Differences in adverse reactions Japan US/EU Dose 10-40 mg 10-4