Do you agree? Data normalization isn’t the finish line. Harmonization is. Even after basic normalization, datasets can drift ...
To describe the standardization process and reliability of anthropometric and bioelectrical impedance analysis (BIA) measurements. We examined both intra- and interobserver errors for skinfolds, ...
One reason given for proactive participation and earlier submission of a monograph was the possibility of prospective or informal harmonization across multiple pharmacopoeias. It is instructive to ...
ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. ICH Q11, the ...
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...
This session, describing harmonized regulations and standards-setting in other sectors, offered two in-depth reports. The first was a look at international harmonization efforts for a completely ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results