RESUMO
OBJECTIVE The purpose of the present study was to investigate the impact of fluvas-tatin formulation on the pharmacokinetics-genetic polymorphis relationship. METHODS We compared the difference between the pharmacokinetics of fluvastatin as an extended-release (ER) 80 mg tablet and an immediate-release(IR)40 mg capsule in terms of drug metabolism enzyme and transporter ge-netic polymorphisms. In this open-label, randomized, two-period, two-treatment, crossover study, ef-fects of BCRP, SLCO1B1, MDR1, CYP2C9, and CYP3A5 polymorphisms on the pharmacokinetics of fluvastatin were analyzed in 24 healthy individuals.Each treatment duration was 7 days with a washout period of 7 days between the crossover.Serum concentration of fluvastatin was evaluated using high-performance liquid chromatography-tandem mass spectrometry. RESULTS The SLCO1B1 T521C genotype had no statistically significant effect on IR 40 mg capsule of fluvastatinafter single or repeated doses.However,for the ER 80 mg tablet,the SLCO1B1 T521C genotype correlated with the AUC0-24of repeat doses (P=0.01). The CYP2C9*3 genotype correlated with the AUC0- 24after the first dose IR 40 mg capsule (P<0.05); however, the difference between CYP2C9*1/*1 and CYP2C9*1/*3 was not statistically significant after repeated doses. CONCLUSION The effect of SLCO1B1 T521C on fluvas-tatin exposure was observed and was more profound in ER and repeated dose administration than in IR and single dose administration.We recommend that formulation should be incorporated into future pharmacogenomics studies and clinical implication guidelines.
RESUMO
OBJECTIVE: To review the development of clinical pharmacy in Europe, analyze the quality assessment system and provide a reference for China. METHODS: By reviewing the literature of European hospital pharmacy or clinical pharmacy services from 1960 to 2013, sum up the development process of clinical pharmacy in Europe and analysis existing quality assessment system. RESULTS: European clinical pharmacy development can be divided into four parts; initial stage ("clinical pharmacy" introduced to hospital), exploring stage ("ward pharmacy service" mode), developing stage ("patient-centered" work system) and mature stage (improving "clinical pharmacists" evaluation system) ; It has formed quality assessment system of pharmacy service structure, process and outcome, but has not yet established a comprehensive system of evaluation criteria. CONCLUSION: Through analyzing and comparing the development progress and quality assessment system of European clinical pharmacy, it is useful to determine a clear direction of Chinese hospital pharmacy and to promote the establishment and improvement of Chinese quality evaluation system.