Faropenem (FRPM) is an oral penem antibacterial medicine with a high stability to beta-lactamase which has a broad antibacterial spectrum and a strong antibacterial activity to gram positive bacteria, and gram negative bacteria, except for Pseudomonas aeruginosa and anaerobic bacteria. The sale of faropene was started in 1997.
Based on the plasma faropenem concentration vs. time data obtained from clinical trials using healthy adult volunteers and patients, and a post-marketing clinical study using advanced age patients, the population pharmacokinetic analysis of a total of 20 studies was performed. The concentration data of 1, 065 points from 218 patients whose creatinine clearances were measured (85 points/12 patients) or estimated (980 points/206 patients) from plasma concentration levels was used for the analysis.
A one-compartment model with first-order absorption was used as a pharmacokinetic model where the absorption lag-time was assumed. Among the population pharmacokinetic parameters, the apparent total body clearance (CL), apparent distribution volume (V), first-order absorption rate constant (k_a) and absorption lag-time (t_iag) showed great inter-subject variation.
In the final model, creatinine clearance (CLcr) was chosen as the most influential covariate against CL and CL was well correlated with CLcr when CLcr was less than 80 mL/min. The inter-subject variability in CL was explained by considering CLcr as a cofactor . The apparent distribution volume increased in the geriatric patients. Both k_a and t_iag were dependent on meals in all patients. Based on these results, the population pharmacokinetic model of faropenem was made by taking these covariates into consideration.
From the results of population pharmacokinetics analysis. the prolongntion of the eliminntion half-lifp (t_1/2) of faropenem was suggested in the patients with decreased kidney function as previously reported.

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Background: From the aspect of biomedical ethics, informed consent is essential for the participant's protection in clinical trials. Informed consent is a process of information disclosure, confirming the participant's understanding and autonomy-driven consent. As a medical professional, a clinical research coordinator (CRC) should possess training in communication skills for supporting the participants' decision-making processes. We conducted informed consent training with simulated patients (SP) for CRC trainees, and evaluated its usefulness as an educational tool.
Methods: Eight new CRC trainees participated in the training between 2003 and 2004. Before the training, all trainees were given an arranged informed consent form of the trial, and they prepared for the interview portion of the training. The trainees explained the trial's content and answered the questions of SP in 20 minutes. Ten items were evaluated for an assessment of basic communication skills by the trainees themselves, SP, and the instructor. This evaluation was scaled at four performance levels (4: excellent, 3: performed well, 2: poor, 1: under-performance).
Results: The average of the total scores evaluated by SP or the instructor was favorably high (34 points), whereas trainees evaluated themselves at a lower average (27 points). Among the items, trainee achievement tended to be lower in the understandable explanation of technical terms and the appropriate behavioral approach to the participant's anxiety.
Conclusions: The informed consent training with SP for CRC trainees is considered to be a useful tool as an evaluation of communication skills of CRC trainees, and when this training is repeated it can be expected to improve the skills of CRC trainees.

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