International harmonization of bioanalytical guidance

“Multiple guidance and regulations create additional burden to performing quality science in a global work place and create potential conflicts with each other in substance and/or interpretation.” Science and regulations both have their place and importance in bioanalysis. We may not know the exact timing of their origin, but bioanalysts know that they have co-existed for many years, and that both have progressed with controlled but constant transformation. One has influenced the other but, by and large, science and regulations have had their individual developmental pathways. When we talk of scientific development, bioanalysis has seen some excellent progress in multiple...