In Japan, there are about 250 Yakushi Buddha (i.e., Buddha of Healing) statues in Buddhist temples. They are listed as Important Cultural Properties and 14 of them are National Treasures. Belief in Yakushi Buddha was especially prevalent from the 7th to the 13th centuries in Japan. The oldest wooden Yakushi Buddha statue is in Horin-ji Temple in Nara. Among the approximately 250 Yakushi Buddha statues, about 200 have medicinal containers-or rarely, a bowl-in the palm of the left hand. However, these medicinal containers are wooden blocks. Very recently, it was found that the Yakushi Buddha statue in the Suho-Kokubun-ji Temple in Yamaguchi Prefecture, Japan has a medicinal container in the palm of his left hand, in which an offering (i.e., 220 g of materials) was found. The date on the reverse side of the lid places the offering at October 12, 1699. The offering is composed of five cereals (rice, barley, wheat, soybean and azuki bean), five medicinal plants (Acori graminei, Acori calami, Ginseng, Flos caryophylli and Lignum santali albi) and six minerals (rock crystals, purple and blue lead glass, CaCO3 particles, and silver and golden foils). Recently, the pharmacy educational program was extended from four to six years in order to meet clinical pharmacy requirements for patients. From studying the Buddha of Healing and its medicinal container described above, the author suggests that, in addition to pharmaceutical bioscience, philosophical concept be studied as part of the history of pharmacy in the future.
PMID: 25799838 [Indexed for MEDLINE]
Valerian has been used as a name for Japanese Valerian and European Valerian root. Valerian in the German market today was originally called Baldrian. Transitions in the standards and the test methods of Valerian root listed in the DAB were studied this time. Moreover, we compared these standards and test methods with those in the USP, BP, EP and JP. We also considered the pharmacology evaluation in Germany. At the time, the standards and test methods had content in accordance with the EP from DAB9 (1986) of the West Germany publication. It also agreed with the EP and BP of the same period. To date in the DAB, botanical features have been mainly derived from the discriminating characteristics of the Valerian root. In DAB9 (1986), standards and test methods were added to the content, enhancing it and making it more stringent. This is thought to have happened as a result of a new, academic finding showing an improvement in the pharmacology level. Valerian root has been listed continuously in the DAB. These listings suggest that Valerian root has continually been evaluated as a sedative. We think that the listing was connected with a relisting in the BP as a result of scientific communications between Britain and Germany, EC member nations, such as through EP publications. On the other hand, the oil made with Japanese Valerian was listed in a radical field in DAB6 (1926) in the past. This is a valuable result, proving that it was used and evaluated as an important herbal medicine from Japan and foreign countries at that time. The Japanese Valerian referred to is not grown in Japan today. Moreover, it is not possible that cultivation will be restarted through good quality revaluation. However, this fact introduces a valuable piece of history supporting the survival of Japanese Valerian and European Valerian root as a sedative in the future.
PMID: 25799839 [Indexed for MEDLINE]
When planning pharmaceutical packaging, the package size for the product is important for determining the basic package concept. Initially, the sales unit for herbal medicines was the weight; however in 1868, around the early part of the Meiji era, Japanese and Western units were being used and the sales unit was confusing. Since the Edo era, the packing size for OTC medicines was adopted using weight, numbers, dosage or treatment period. These were devised in various ways in consideration of convenience for the consumer, but the concept was not simple. In 1887, from the time that the first edition of the Japanese Pharmacopoeia came out, use of the metric system began to spread in Japan. Its use spread gradually for use in the package size of pharmaceutical products. At the time, the number of pharmaceutical units (i.e., tablets), became the sales unit, which is easy to understand by the purchaser.
PMID: 25799840 [Indexed for MEDLINE]
The cancer therapies currently available do not yet offer fully satisfactory treatments, even in 21st century, and efforts and progress are being made daily in the area of drug development. Anticancer drugs, which play the leading role in cancer therapy, are being developed dynamically around the world, and Japan is not an exception. Looking back on the history of developing anticancer drugs, cytotoxic drugs were the mainstream of drug development until the end of the 20th century. In the 21st century, they have been replaced by molecularly targeted drugs, and thus the development of cytotoxic drugs has been declining rapidly. There were various approaches to the development of anticancer drugs and clinical trial endpoints until the 1980s. In 1991, the Guidelines for Clinical Evaluation Methods of Anti-Cancer Drugs in Japan was issued. From 2000 onwards, there was vigorous discussion on the clinical trial endpoints of anticancer drugs in the United States. In conjunction with this discussion, the Guidelines for Clinical Evaluation Methods of Anti-Cancer Drugs in Japan was revised in 2005. The revised guidelines required survival data at the time of filing a new drug application (NDA) as a general rule. Around 2005, a bridging strategy was promoted as the International Conference on Harmonization E5 was promulgated among Japan, the U.S. and EU, resulting in an outflow of clinical trials to overseas, with more non-Japanese survival data generated outside of Japan used for NDAs than Japanese data. Subsequently, the Guideline for Basic Principles on Global Clinical Trials was issued in 2007, which promoted the change in the mainstream approach from a bridging strategy to a pivotal, global study involving Japan. Thus, an era of full-fledged globalization in clinical trials began. We believe Japan will need systems to enhance the motivation for anticancer drug development, such as an expedited program or pediatric program, from now on. We hope that the enhancement of these systems will contribute to shortening the period required for approving an anticancer drug and reducing developmental costs. Furthermore, we expect Japan to be creating breakthrough anticancer drugs in the near future.
PMID: 25799841 [Indexed for MEDLINE]
In Japan, biologics have been described as special sorts of medicines in the Pharmaceutical Affairs Law and are regulated by the Ministry of Health, Labour and Welfare (MHLW). In contrast, in the United States, some of the regulatory laws for biologics are different from other medicines and the relevant regulatory agencies have been changed historically. We reviewed the histories of the laws and changes in regulatory agencies for biologics, especially focusing plasma fractionation products in the United States, which may give suggestions and advice for the regulation of biologics in Japan. In the earliest stage, biologics were regulated by the Biologics Control Act (BC Act) of 1902 and as parts of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938. The effectiveness of these regulations was not equivalent to that of other drugs; therefore, Congress passed some amendments to the FD&C Act, in which biologics were treated in the same way as other drugs. In 1972, the authority for biologics control was transferred from the National Institutes of Health (NIH) to the Food and Drug Administration (FDA). Thereafter, in order to achieve the most efficient regulation under the rapidly evolution of biologics, the biologics regulating sections in the FDA have changed several times. At present, some biologics that are used in ways similar to other drugs (e.g., cytokines, monoclonal antibodies and immunomodulators) are regulated by the Center for Drug Evaluation and Research (CDER), and other biologics (e.g., vaccines, blood products and cellular products) are regulated by the Center for Biologics Evaluation and Research (CBER) of the FDA.
PMID: 25799842 [Indexed for MEDLINE]