PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 15 , Issue 1
Showing 1-5 articles out of 5 articles from the selected issue
Regular Article
  • Kinya KOKUBO
    2013 Volume 15 Issue 1 Pages 1-9
    Published: 2013
    Released: August 31, 2013
      Using quantitative analysis, this paper aims to clarify the effects that M&A activities and technological alliance among major domestic pharmaceutical companies have on the principle determinants of innovation. In the analysis, we used data obtained from 43 companies that responded to a questionnaire targeted at major domestic pharmaceutical companies. The results of the analysis suggest the following: (1) While R&D investment and M&A activities can be seen as a substitute for each other as a strategy of major domestic pharmaceutical companies, no such complementary relationship exists between M&A activities and technological alliance. In addition, technological alliance was found to have the effect of diversifying technological opportunities. (2) In M&As among major domestic pharmaceutical companies, the focus is on the appropriability of securing exclusive rights and horizontal integration is carried out in pursuit of larger scale. In seeking appropriability exclusive rights, emphasis is placed on the “preventing patent imitation,” “securing patent royalties,” and “building profits through sales and services.” (3) In merger and integration deals among major domestic pharmaceutical companies, although the appropriability of securing exclusive rights is higher, a trade-off relationship can be seen in which diversification of technological opportunities cannot be realized. (4) In addition to horizontal M&As, major domestic pharmaceutical companies go for vertically-integrated M&A deals with the aim of obtaining biopharmaceuticals. In this research, many issues still remain to be studied. The first issue is that the sample size is only 43 in the quantitative analysis. The second issue is that the causal relationship and direct effect on innovation cannot be derived from the estimation range. Finally, the analysis of the subject companies is limited to a certain period and the performance of the companies after their M&As and technological alliance have not been pursued further.
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Topics Review
  • Daikichiro MURAKAMI
    2013 Volume 15 Issue 1 Pages 10-12
    Published: 2013
    Released: August 31, 2013
      Recently, pharmaceutical and medical device industries have been facing a great impact of the globalization trend to International Harmonisation in ICH, IMDRF.
      Thereupon, not only regulatory organizations but also other relevant various bodies or associations should have made every possible effort to translate important pharmaceutical and medical decices lawas, regulations, and guidelines into Japanese.
      Although the “International Harmonisation” has been translated into Japanese as “Chowa”, AHWP and ISO committees in Japan has made a different translation for that; namely, it is Seigouka.
      Two different translated words in Japanese apparently provide us with two different meanings for the same English.
      Hereupon, I would review them to clarify the definite difference between them through my understanding.
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Technical Report
  • Haruo NISHI
    2013 Volume 15 Issue 1 Pages 13-19
    Published: 2013
    Released: August 31, 2013
      Water for Injection abbreviated as “WFI” is allowed to be produced by distillation or membrane filtration of RO and/or UF even in the 16th Japanese pharmacopoeia.
      The distillation has most widely been applied in the injections for practical use from the dawn of the injection up to the present, and water stills are usually divided into single effect type, thermo compression type, and multi-effect type.
      Especially, the multi-effect water still hereinafter abbreviated as “MWS” was originally developed in a Finnish maker in 1970's, and various kinds of improvement has been introduced by several still manufacturers since then.
      Some types of MWS are used with either downward-filmy flow effect or natural water circulation effect each of which is adopted as evaporation system.
      Herein, a highly efficient MWS, which adopts a vertical filmy water-flow system, is introduced because it is characterized as short time startup into operation with little holding water. This type of MWS should meet the latest international GMP, ICH/Q9 (quality risk management), ASME-BPE (Bioprocess Equipment of the American Society of Mechanical Engineers), and any pharmaceutical manufacturing guidelines.
      Consequently, the new MWS considered with an optimum mechanism has now been developed to function as a next generation type devised by a risk-based approach.
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Topics Review