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product development is that of a highly dispersed process that capitalizes on the skills and insights of people and organizations spread throughout the entire world. However, the benefits of dispersion come at a cost.
Method development (Figure 2) is a continuous process that progresses in parallel with the evolution of the drug product. The notion of phase-appropriate method development is a critical one if time, cost, and efficiency are concerns. The goal and purpose of the method should reflect the phase of drug development. During early drug development, the methods may focus on API behavior.