Analytic method development is a key element of any pharmaceutical drug development program. Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. Method development is a continuous process that progresses in parallel with the drug development.
The goal and purpose of the method should reflect the phase of drug development. During early drug development, the methods should be suitable to support pre-clinical safety evaluations, pre-formulation studies, and product stability studies. Up to and including clinical trial Phase 1, analytical methods need only be qualified, not validated. Linearity, precision, accuracy, and specificity will suffice at this stage.
As drug development progresses, the analytical methods are refined and expanded, based on increased drug product knowledge and method validation must be completed as the drug progresses through Clinical trial Phase 2 and Phase 3, and commercialization.