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  • 1.  CMC Reference Book

    Posted 08-Nov-2011 18:02

    I am looking for a CMC reference book that outlines the GMP and other regulatory requirements/recomendations for Phase 1, Phase 2 and Phase 3 production. Even better if it also covers EU requirements.
    Thank you.

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    Susan Sullivan
    Omeros Corporation
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  • 2.  RE:CMC Reference Book

    Posted 12-Nov-2011 08:15
    Dear Susan

    interesting question. Though there may be some publications out there that cover some aspects (I presume you searched the raps.org and topra.org websites), there is an awful lot of information / knowledge that is managed through in-house manuals within companies.

    These may well be a real gap in the publications list and I'd be very interested to know if you can find what you are looking for. If not, this could be an interesting publication project

    Regards
    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 3.  RE:CMC Reference Book

    Posted 13-Nov-2011 09:54

    A book that is focused on biopharmaceuticals is "The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, Author: John Geigert, published by Kluwer Academic / Plenum Publishers, New York.
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    Elizabeth Fowler
    Brunswick ME
    United States
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    Original Message