TQT Analysis in Japanese and Caucasian Volunteers

Posted:
15
March 2011

As a feature of this year�s 84th annual meeting of the Japanese Pharmacological Society (JPS) taking place March 22nd to 24th in Yokohama Japan, the first ever formal Japanese Caucasian bridging TQT analysis is due to  be presented by Professor Sugiyama of Taiho University and Dr Jorg Taubel of Richmond Pharmacology Ltd.  The analysis was carried out jointly between the Department of Pharmacology of Toho University, the Cardiovascular Sciences Research Centre at St Georges University of London and Richmond Pharmacology Ltd.Japan and BeyondIn 2010, Japan adopted the ICH E14 guideline requiring the submission of TQT studies for new product license applications which may need to be done partly or fully in Japanese subjects.In 1998, the International Conference on Harmonisation (ICH)  Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data  (E5) was adopted.  This, coupled with the acceptance of the PDMA in 2007 of clinical data from non-Japanese patients, has helped to bring NCE s to the Japanese pharmaceutical market in both a cost and time efficient manner.Trust Well Invested (E5) was adopted.  This, coupled with the acceptance of the PDMA in 2007 of clinical data from non-Japanese patients, has helped to bring NCE

  • TQT Studies in Japanese and other ethnicities
  • First-in-Japanese
  • Ascending Single and Multiple  (SAD and MAD Studies)
  • Combined protocols such as bridging, SAD and MAD and food effect

Partnering with JapanIn order to facilitate the collaboration with Japanese sponsors, RICHMOND PHARMACOLOGY is also partnered with AcroNet, a Japan based full service clinical CRO.  Acronet provide a high quality, expert service and like Richmond Pharmacology, are dedicated to the development of the pharmaceutical and medical field and most importantly people's health.

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