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Regulatory challenges for nanosimilars

  • In: Pre-satellite on Nanomedicines - Tackling the challenges of nanomedicines: Are we ready? on Sunday, 22 September 2019, 9:00-13:00
  • At: AbuDhabi (United Arab Emirates) (2019)
  • Type: Presentation
  • By: SHAH, Vinod (NBCD Working Group, USA)
  • Abstract:

    Nanomedicines are typically synthetic and belong to Non-Biological Complex Drug Products (NBCDs). The high complexity relates to their composition of closely related but not homomolecular, often nanoparticular structures.  The regulatory approval of NBCDs is challenging because of the difficulties in complete characterization of the drug product


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Last update 28 September 2023

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