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SMEs Requested - USP Publishes Product-Specific Emerging Biologics Standards for Public Comment

  • 1.  SMEs Requested - USP Publishes Product-Specific Emerging Biologics Standards for Public Comment

    Posted 3 days ago

    Dear AAPS Pharmaceutical Quality team,

    AAPS is considering a response to four draft US Pharmacopoeia analytical method standards. Please see below message. The four standards are:

    - Methods for the Analysis of Bevacizumab - https://emergingstandards.usp.org/emerging-standard/methods-analysis-bevacizumab
    - Methods for the Analysis of Rituximab - https://emergingstandards.usp.org/emerging-standard/methods-analysis-rituximab
    - Methods for the Analysis of Interferon Beta-1A - https://emergingstandards.usp.org/emerging-standard/methods-analysis-interferon-beta-1a
    - Methods for the Analysis of Epoetin - https://emergingstandards.usp.org/emerging-standard/methods-analysis-epoetin

    As these are emerging standards, this topic seems quite relevant to the PQ Team.

    However I wanted to open it up to the broader team to consider your thoughts to the below questions:

    1. Does PQ community feel AAPS should respond? Yes/No
    2. If yes, who from the PQ team would volunteer their expertise to represent PQ on the Response Team?

    Please let me know by EOB June 10.

    Thank you,

    Joe


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