Efficient designs for the estimation of mixed and self carryover effects
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Date
2018
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Abstract
Biosimilars are copies of biological medicines that are developed by a competitor
after the patent for the originator drug has expired. Extensive clinical trials are
required to show therapeutic equivalence between the biosimilar and its reference
product before a biosimilar can be sold on the market. However, even after more
than 10 years of experience with biosimilars in Europe, there is still some uncertainty
if the patients who are already taking the reference product can switch between
the biosimilar and its reference product. One convenient way to assess the impact
of switches is the analysis of mixed and self carryover effects: if the products are
switchable, there should not be any difference in the carryover effects. This paper
determines a series of simple designs which are highly efficient for the comparison
of the mixed and self carryover effects of two treatments. The proof of efficiency
is not straightforward because the information matrix of the efficient designs is not
completely symmetric.
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Keywords
A-optimality, switchability, linear model, crossover designs, biosimilars