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Stability data for registration

  • 1.  Stability data for registration

    Posted 20-May-2021 04:19
    Dear community,

    Ask you to help with stability data for registration in EMA. We need to registrate biological drug product for intravenous ingection (like human immunoglobulin).
    Could we study stability  for drug product by 1 strenth(concenrtation) based on data just for 1 batch ?
    Or could we study stability  for drug product by 1 strenth(concenrtation) based on data for 3 batch but different sizes of conteiner?

    Best regards.

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    Kateryna Leshchenko
    BIOPHARMA PLASMA LLC - ENTERPRISE
    Bila Tserkva
    Ukraine
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