"Harmonization" should mean stressing compatibility of inferences about underlying pharmacokinetics and modes of action and using the insights developed in dissecting the underlying biology of different endpoints to inform our understanding across endpoints.
Although one can hardly be against harmony and for discord, it is important to realize (taking the metaphor of "harmony" as a model) that harmonization does not mean that an identical method needs to be applied to all cases for all agents and disease endpoints.
PQT employs concept harmonization, not derivation, which means that specific study variables are mapped to disease domain variables while still preserving the variable's study-specific definition.
Given that it is possible to use the SHERPA interface with other types of data, SHERPA can also be seen as a means to foster harmonization in the field of model evaluation.
As a measure of harmonization of reconstruction conditions, the root mean square error (RMSE) was measured; RMSE is the square root of the variance in SUVmean of the six spheres between DRO17 mm and actual phantom images obtained with the SPECT/CT cameras.
Ghana and Nigeria have similar drug regulatory structures based on the US FDA system, and we observed that personal linkages between executives of the FDBs in both countries meant that discussions on regulatory harmonization have taken place.
This means that the leaders of regulatory harmonization will be the ones where the level of precaution is the highest -- in the most developed countries.
Respondents identified the following as the greatest benefits of TGx data sharing: identification and consensus-building around novel biomarkers, standardization and harmonization of approaches and interpretation, and providing a means to inform the regulatory community about the application of TGx data.
The performed approach was validated in accordance with the guidelines of the International Conference on Harmonization (ICH) and the robustness of the method was proven by means of the effect plot.
Looking at the figures from the accounts of the four hospital trusts within northern Norway, the costs increased by 26%54%% (mean 34.5%) from 2007 to 2008, indicating a harmonization of the costs within the region.
