The use of truncated area under the curves in the bioequivalence evaluation of long half-life drugs. Studies with donepezil and memantine.

摘要: The bioequivalence of long terminal half-life drugs, donepezil (CAS 120014-06-4) 10 mg and memantine 19982-08-2) mg, was evaluated by comparing the results obtained for total areas under concentration time curves (AUC(0–inf)) with those partial AUCs: AUC(0–216h), AUC(0–72h) AUC(0–48h). Pharmacokinetic endpoints were determined standard formulas from concentration-time courses parent compounds memantine. assessment based on 90% confidence intervals calculated means ANOVA logarithmically transformed values (ANOVA log) led to exactly same decision irrespective type AUC used. all types AUCs practically identical within each product. These prove that truncated AUCs, e.g. or even AUC(0–48h), can be adequately used in assessing relative bioavailability drugs. findings suggest drugs half-lives between 24 60 h thus shorter than an 48 post dose successfully as this sample collection ensures a proper comparison absorption process recommended CPMP Note Guidance Investigation Bioavailability Bioequivalence.