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- W2357005651 abstract "Objective To introduce the design and analysis of the bioequivalence(BE) of endogenous drugs by the urine data of potassium citrate.Methods According to the FDA documents on the clinical BE study of endogenous drugs and other literature,the key issues including study flow,dietary and housing considerations,the dose choice,collection of samples and data analysis,were discussed in the bioequivalence study of potassium citrate.Results The BE of potassium citrate was designed as a single-dose and two-way crossover study.The subjects were assigned on a standardized diet and kept in a climate-controlled environment.The baseline urinary excretion(the average of at least two readings obtained on the two baseline days) of potassium and citrate were subtracted from the amount obtained on the drug dosing day,and the BE analysis was done according to the baseline-adjusted parameters(Ae0-24h: cumulative urinary excretion from 0 to 24 hours,Rmax: maximal rate of urinary excretion).Conclusion It is a complicated design for the study of the BE of endogenous drug,and susceptible to diet and homeostatic mechanisms.The correction for baseline levels is mandatory,which leads significant variances of the parameters for analysis(Ae0-t and Rmax).Other parameters such as Tmax and T1/2 are not applicable to evaluate BE." @default.
- W2357005651 created "2016-06-24" @default.
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- W2357005651 date "2011-01-01" @default.
- W2357005651 modified "2023-09-23" @default.
- W2357005651 title "Design and analysis of the bioequivalence trial of endogenous drugs based on urine data" @default.
- W2357005651 hasPublicationYear "2011" @default.
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