Independently of their status with respect to pharmaceutical equivalence or in vitro activity, all generics failed therapeutic equivalence in vivo, displaying significantly lower Emax and requiring greater BD and 1LKD, or fitting to a non-sigmoidal model.
4 generic products failed pharmaceutical equivalence due to significant differences in potency; however, all products were undistinguishable from the innovator in terms of MIC and MBC.
Here, we demonstrated that even pharmaceutically equivalent products of gentamicin may fail therapeutic equivalence compared with the innovator in the same animal model used in preclinical studies [21].
If this assumption fails, the equivalence between the strong metric subregularity and the strong metric regularity may be a failure.
Gilead Sciences fell 6% on Wednesday after the biotechnology firm said the first formulation of a combination HIV drug failed to show equivalence biologically, compared with taking the drugs separately.
28 Moreover, the drug failed to demonstrate equivalence to efavirenz (both in combination with zidovudine and lamivudine) in antiretroviral naïve patients (MERIT study), 29 probably due to emergence of X4-using variants undetected at baseline.
22 Analysis of definite and probable cases only and definite cases alone just failed to show equivalence: in the first case the upper bound of the 95.5% confidence interval around the point estimate of the cumulative incidence in the percutaneous group lay marginally above the 25% band and in the second case marginally below the band.
Since 95% CI was not within the pre-specified equivalence margin of ± 5%, we failed to accept the equivalence hypothesis.
Bevacizumab, as needed, failed to meet NI equivalence to monthly ranibizumab, that is, bevacizumab used in a PRN regimen did not reach the superior visual outcome achievable with monthly ranibizumab.
However, our assumptions of functional equivalence fail to consider the opportunity for divergence conferred by ~180 Million Years (MY) of independent evolution between these species.
