Journal of Clinical & Experimental Pathology
Open Access

Abstract

The recent (and ongoing advancements in analytical techniques and methodologies have resulted in a resurgence in the application of analytical test methods to analysis of molecules (both chemical and biological). This presentation will present a well-established systematic way of developing a robust analytical strategy that is compliant with both ICH Q6B requirements and with the molecule requirements. This knowledge-based approach can be best described as orthogonal/multi dimensional enabling components attributes and performance attributes to be established following a theoretical and practical approach.

Biography