On safety margin for drug interchangeability
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DOI: 10.1080/10543406.2016.1265540
Abstract: ABSTRACT As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can… read more here.
Keywords: safety; generic biosimilar; biosimilar drug; drug ... See more keywords
On hybrid parallel–crossover designs for assessing drug interchangeability of biosimilar products
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DOI: 10.1080/10543406.2017.1275956
Abstract: ABSTRACT In recent years, a specific hybrid parallel–crossover design that consists of two sequences of treatments, namely R–R–R–R and R–T–R–T, where T and R is a proposed biosimilar product and an innovative biological product, respectively,… read more here.
Keywords: crossover; parallel crossover; drug interchangeability; hybrid parallel ... See more keywords