https://www.selleckchem.com/pr....oducts/rilematovir.h
In general, similar to FDA and other health authorities, the PMDA requires clinical efficacy study(ies) to evaluate equivalence between a reference biological product and a Biosimilar product for new drug applications. Even if an identical clinical efficacy study is included in both of PMDA and FDA submissions, the coefficients of confidence interval (CI) used for comparison with the equivalence margins could be different between the two submissions (e.g., 95% CI vs. 90% CI). In this article, we will focus on clinical efficacy studi
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