Mianserin suppositories were formulated to treat symptoms of delirium and depression. Pharmacokinetics were assessed by measuring blood concentrations of mianserin in healthy older Japanese male adults. The effects of 20 mg mianserin suppositories were evaluated in three healthy older male adults. Mianserin concentration in blood was measured using gas chromatography-mass spectrometry. t_max was 14.7±8.1 h; C_max was 7.0±1.4 ng/mL; AUC₀₋₄₈ was 196.7±19.6 h・ng/mL; and AUC_0−∞ was 264.9±38.3 h・ng/mL. Compared to young male adults, older male adults demonstrated delayed t_max, lower C_max, and lower AUC_0−∞, suggesting a lower absorption rate through the rectal mucosa. These results demonstrate differential pharmacokinetics of mianserin suppositories in younger versus older adult men.

This research aimed to investigate the significance from the viewpoint of safety and educational effect of introducing a human study program using diuretics in practical pharmacology for medical students at Showa University. A study with a 4-way crossover design was conducted, in which single doses of three types of diuretics and placebo were administered to healthy adult subjects on different days. The characteristics of the mechanism of action of each diuretic were evaluated up to four hours after dosing. Safety was evaluated, and the precision of a simple assay of urinary electrolytes using DryChem^® was examined. All the diuretics could be discriminated based on urinary electrolyte concentrations and changes in urine volume. Although it is necessary to adjust the doses of diuretics taking into account the physique of the subjects, introducing this program as a session in practical pharmacology was considered feasible and to have high educational significance.

The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) introduced the clinical research coordinator (CRC) certification program in 2003, and 1,765 CRCs have been certified as of January 1, 2018. The situations of these certified CRCs have not been investigated since the Special Task Force of Clinical Trials, Japanese Society of Hospital Pharmacists conducted a questionnaire survey in 2007.

This study was conducted by administering an e-survey to certified CRCs regarding their background, current situation, career, intentions, and job satisfaction. The 668 respondents comprised 37.8% of the population of certified CRCs. We further examined the situations of 568 (85.0%) respondents currently employed at a CRC job.

When comparing the responses of the present survey to the results of the 2007 survey, improvement was observed regarding the questions on employment status and “whether they can continue the job as CRC” , but it appeared that the attempts were still halfway through. Although many of the CRCs reported a positive attitudes toward their CRC work, not many of them responded that they were not thinking of changing to jobs other than CRC. This suggests the existence of factors that hinder continuation of the career as CRC. While unstable employment seems to be a factor, other factors such as staff shortage and uncertainty regarding the future career may have precipitated this intention. In conclusion, the survey results suggest that although the CRC working environment is improving, CRC jobs are not yet stable.

The clinical research coordinator (CRC) certification program was initiated by the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT) in 2003. As of January 1, 2018, 1,765 CRCs have been certified.

However, the current situations of these certified CRCs have not been investigated in detail.

Six hundred and sixty-eight certified CRCs responded to an e-survey regarding the background, current situation, career, intentions, and job satisfaction. The first report found that although the work environment was improving, it was not yet stable. However, the current situations of certified CRCs and the contribution of the accreditation system to their situation were not clear. Therefore, this report explores the current status of accredited CRCs and considers the future issues of developing CRCs ' skills and career path.

The respondents reported that the contribution of CRC to clinical research was very important, and what was required of CRC as a professional in clinical research continued to increase. However, the survey revealed the existence of a gap between the current situation and demand from the society, such as lack of a CRC career ladder aiming at gradual mastery of expert knowledge and skills, little merit in acquiring CRC certification, and the certified CRC system not keeping pace with diversification of work style. In summary, solving the above issues would help develop CRC in clinical research.