JKS Reports: Guidance on Pharmacogenomics, QT Interval Prolongation

New documents are available in the JKS Document Store , click on the links below to read more:

Publication date Title Comments
June 13, 2005 21st New Drug Information Meeting 

Report of the meeting held on
May 26, 2005 in Tokyo

Key topics: drug review and approval, guidance on pharmacogenomics, clinical trials under the new Japanese regulations, the Government approach to the unapproved medicinal products, especially for advanced anti-cancer therapy, future clinical trials under the "Three-year Clinical Trials Revitalization Plan". For the first time in English the program and the key announcements, formatted, indexed, annotated, hyperlinked and illustrated - 12 figures, over 30 editor's notes, references, 52 pages.

June 27, 2005 12th ICH Immediate Briefing

Report of the meeting held on
June 21, 2005 in Tokyo

Concise summary of the proceedings of the meeting held by the Japanese regulatory authorities to announce/explain the most recent developments in the ICH process with emphasis on the Japanese participation. Key topics: pharmacopoeial interchangeability, dictionaries and data exchange, QT prolongation problem (proarrhythmic potential for non-antiarrhythmic drugs), and pharmacovigilance.

1999-2005 Japan Approvals Database (JAD)

Subscribe to the only English-language database of approved pharma products in Japan - available for 1999-2005 period - more info

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