All reference standards articles

  • Licensed image
    Journal

    Unique aspects of biologic reference standards

    2025-01-10T08:50:00Z

    Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards as outlined by the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B and Q7 guidelines. It addresses types of standards based on source and use, with particular emphasis on the distinct requirements for biologics.

  • licensed RegRap cover image_compressed
  • RR-Jan-2025- half cover
    Contents

    January 2025 – Contents

    January 2025  |  Vol. 22  |  No. 1