2006-09-08-世界卫生组织-INN_48th_Executive_Summary_7页_124kb
报告摘要
48th INN Consultation Summary
Program Overview
- Date & Location: March 31 – April 2, 2009, Geneva.
- Attendees: INN Expert Group members, INN Advisory Group on biologicals, WHO INN Secretariat, and specialists.
- Key Note: Dr. Sabine Kopp welcomed attendees, emphasizing the INN Program's importance in global medicine; the Expert Group's work is reported to the Expert Committee on Specifications for Pharmaceuticals Preparations. Chemical substances are prioritized for naming, with criteria ensuring uniqueness and clarity.
Nomenclature Discussions
- Name Selection: Out of 89 total requests, 77 were selected or reconfirmed for publication in List 102; 5 deferred or rejected, while 1 was abandoned or substitution requested.
- Challenges with Complex Compounds:
- Glycoproteins: Greek letters (e.g., alfa, beta) are used in INNs for products with post-translational modifications like glycosylation. Challenges include defining structures and avoiding conflicts with existing naming systems (e.g., interferons).
- Monoclonal Antibodies (Mabs): A working group recommended simplifying stems and infixes, retaining "-mab" post-stem classification. They agreed INFIXES should use fewer syllables and avoid redundant categories, with further details recommended for publication.
- Action & Use Statements (AUS): A revised framework for stem classification was discussed; suggest grouping for CNS depressants, anti-pyretics, and gene therapies, with ongoing updates.
Collaboration Updates
- USAN/BAN: New names approved and website updates reported.
- EMEA/FDA/WIPO: Advances in drug nomenclature and sponsor roles; WIPO raised concerns about INNs being used in domain names, recommending heightened oversight.
- IUPAC/DG TAXAUD: Contributions to polymer nomenclature and trade agreements affecting pharmaceutical access.
Data Management Enhancements
- IDMIS: Web-based system improved; feedback introduced, archive access planned.
For the 49th Consultation scheduled for November 2009, key themes include refining nomenclature standards and addressing collaboration challenges.
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