Statistical considerations for confirmatory clinical trials for similar biotherapeutic products.

  title={Statistical considerations for confirmatory clinical trials for similar biotherapeutic products.},
  author={Catherine Njue},
  journal={Biologicals : journal of the International Association of Biological Standardization},
  volume={39 5},
For the purpose of comparing the efficacy and safety of a Similar Biotherapeutic Product (SBP) to a Reference Biotherapeutic Product (RBP), the "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" issued by the World Health Organisation (WHO), states that equivalence or non-inferiority studies may be acceptable. While in principle, equivalence trials are preferred, non-inferiority trials may be considered if appropriately justified, such as for a medicinal product with a wide… CONTINUE READING

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