Construct · 1 fields · 1 citations

totality of the evidence approach: a standalone construct

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totality of theevidence approach1 CONSTRUCTTotality of the evidenceKOZLOWSKI · BIOPHARMACEUTICAL

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Biopharmaceutical development

judging a copy biologic by weighing analytical, functional, nonclinical and clinical comparisons together rather than one trial.

In biopharmaceutical development, totality of the evidence approach refers to judging a copy biologic by weighing analytical, functional, nonclinical and clinical comparisons together rather than one trial. This meaning comes from Kozlowski (2011) in New England Journal of Medicine.[1]

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development1 fields · 2 citationsanchor · a standalone constructevidence2 fields · 4 citationsjingle · one word, two constructs

References

  1. Kozlowski, S., Woodcock, J., Midthun, K., & Behrman Sherman, R. (2011). Developing the Nation's Biosimilars Program. New England Journal of Medicine, 365(5), 385-388. https://doi.org/10.1056/nejmp1107285

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