Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan.

We outlined five studies regarding the quality of the review by committees based on the Act on the Safety of Regenerative Medicine. The findings raise serious concerns about the independence, integrity, and quality of reviews of therapeutic plans by these committees with inappropriately close relationships to medical institutions and companies.

Impact of shipping emissions on air pollution and pollutant deposition over the Barents Sea.

Arctic warming leading to reduced summertime sea-ice is likely to lead to increased local shipping especially along the Northeast Passage near the northern coasts of Norway and Russia, which are shorter than the traditional southerly routes. Here, the regional chemistry-transport model WRF-Chem is used to examine the effects of shipping emissions on levels of air pollutants and deposition fluxes over the Barents Sea both for present-day and future conditions, based on a high growth scenario. Present-day shipping emissions are found to have already substantial effects on ozone concentrations, but limited effects on sulphate and nitrate aerosols. Predicted future changes in ozone are also important, particularly in regions with low nitrogen oxide concentrations, and results are sensitive to the way in which diversion shipping is distributed due to non-linear effects on photochemical ozone production. Whilst modest future increases in sulphate and nitrate aerosols are predicted, large enhancements in dry deposition of sulphur dioxide and wet deposition of nitrogen compounds to the Barents Sea are predicted. Such levels of future nitrogen deposition would represent a significant atmospheric source of oceanic nitrogen affecting sensitive marine ecosystems.

Bioequivalence and rapid absorption of zolmitriptan nasal spray compared with oral tablets in healthy Japanese subjects.

BACKGROUND AND OBJECTIVE: Oral zolmitriptan is highly effective in the acute treatment of migraine. However, nausea and vomiting during attacks may limit the usefulness of oral medications. An alternative, nasal spray, formulation has been developed that demonstrates good efficacy, high tolerability and a very fast onset of action. This study assessed the pharmacokinetics and bioavailability of zolmitriptan and its active metabolite 183C91 in healthy Japanese subjects following single-dose (2.5 or 5mg) oral or intranasal administration. METHODS: This was a single-centre, open-label, randomised, crossover study. Forty-eight subjects each received one oral and one intranasal dose of 2.5 or 5mg zolmitriptan, with a 72-hour washout period between doses. Blood was drawn at various timepoints from 2 minutes to 15 hours post-dose and urine was collected over the course of the study; samples were analysed for zolmitriptan and 183C91, from which pharmacokinetic parameters were calculated. RESULTS: Zolmitriptan was detected in plasma 2 minutes after intranasal administration in the majority of subjects (~75%) compared with 10 minutes after oral administration. The intranasal : tablet ratio for zolmitriptan area under the concentration-time curve from time zero to infinity was 0.924 (90% CI 0.826, 1.033) and 0.960 (90% CI 0.865, 1.066) for the 2.5 and 5mg doses, respectively. Other pharmacokinetic parameters were similar between the two formulations. While 183C91 appeared in the plasma concurrently to zolmitriptan after oral dosing, its appearance was delayed to approximately 30 minutes after intranasal dosing. Zolmitriptan was safe and well tolerated at both doses. CONCLUSIONS: The rapid absorption of zolmitriptan nasal spray may explain the faster relief from migraine reported in patients compared with oral zolmitriptan.