PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 16 , Issue 2
Showing 1-3 articles out of 3 articles from the selected issue
  • Thomas Thorpe, Hiroshi TAMAZAWA
    2014 Volume 16 Issue 2 Pages 29-37
    Published: 2014
    Released: September 23, 2014
      Purchasing, validating, maintaining and operating container/closure cleaning and sterilization/depyrogenation equipment for periodic use in aseptic filling demands human, financial, and floor space resources an organization can better allocate elsewhere in small-scale drug development. In this paper, the authors describe how the innovative pre-packaged Ready-to-Fill® sterile components are cGMP-prepared suitable for aseptic filling and indicate the various benefits to pharmaceutical companies and medical institutions of all sizes.
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  • Kinya KOKUBO
    2014 Volume 16 Issue 2 Pages 38-46
    Published: 2014
    Released: September 23, 2014
      Uncertainty concerning pharmaceutical industry R & D continues to grow, which is making it increasingly difficult to introduce new drugs to market. This paper presents a hypothetical exploratory analysis of factors that affect the translation of new drug discoveries to clinical research.
      The first factor is the organizational capability to maintain propriety throughout the drug development process, either through technological superiority or the accumulation of organizational capability. Second, Patent protection is important in order to avoid the follow from other companies. Third, within the pharmaceutical industry, technological superiority is more important than accumulating organizational capability as a factor for promoting protection through patents. However, it was shown that the accumulation of organizational capability affected organizational capability to build technological superiority.
      These findings point to future research directions that incorporate cross-sectional data across multiple industries. Moreover, further studies could explore in detail how accumulating organizational capability builds technological superiority. There are some variables that have not been considered in this study.
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