Japanese drug

In addition, the Japanese normally insist that at least some clinical trials be carried out in Japan itself. This position is adopted due to, for example, differences in body size and metabolism of Japanese, compared with US and European citizens. Also, the quantity of active ingredient present in Japanese drugs is lower than in many other world regions. Hence, trials must be undertaken to prove product efficacy under intended Japanese usage conditions. 

GMP compliance certificates for Japanese drug plant have been issued since 1982 today bilateral agreements have been signed with the United States and EU since May 2003, with regard to GMP compliance recognition. 

As can be seen, the structure of a Japanese drug label is a standard format that would also be familiar to physicians in Europe or North America. 

Table 38.1 Subtitles that must appear in Japanese drug labeling, and the order in which they appear (after Article 52, Item 1 of the Pharmaceutical Affairs Law)...

Despite their virtually universal control over prescription reimbursement rates, the Japanese ranked first and second in per-capita pharmaceutical spending in 1987 and 1988, respectively (139,361). This spending seems odd because Japanese drug prices were drastically cut by a total of 52 percent from 1981 to 1990. To explain such high pharmaceutical expenditures in the face of the price cuts of the 1980s, one must look at how drugs are delivered in Japan. 

In chemical and pharmacological investigations of the Japanese drug "sen-bushi", the roots of A. oavmiohaeli, Japanese workers S... 

Table 31.2 Sub-sections of precautions in Japanese drug labeling...

Japta List Japanese Drug Directory, Third Edition, Japan Pharmacetucial Traders Association Tokyo, Japan 1987, p. 395. 

Constituents of Japanese drug (foyakosi) obtained from roots of Ar gelica glabra MaMno. Pale yellow tablets. M.p. 106°. [a]n + 35-8° in Py. Aik. HjOj —> furm-2 3 -dioarboxylio add. 

Fujieda M, Yamazaki H, Kiyotani K, Muroi A, Kunitoh H, Dosaka-Akita H, Sawamura Y, Kamat-aki T (2003) Eighteen novel polymorphisms of the CYP2A13 gene in Japanese. Drug Metab Pharma-cokinet 18 86-90... 

Constit. of Japanese drug byakusi obt. from Angelica spp. Mp 117-118°. Opt. rotn. data inaccessible but is thought to be dextrorotatory. 

Chlormethinum (4.19) is not in circulation long enough to be fully effective. The Japanese drug Nitromin (12.35) was introduced to overcome this disadvantage the slow reduction of the AT-oxide ftmction gradually liberates the true drug (Druckrey, 1955). It is as effective orally as parente-rally. Its action is mild and it is in regular clinical use for the more easily controlled conditions. 

---