Module 3 2019

Early Development: Method Confidence

• Same attrition arguments apply to effort expended on method development as method validation

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Material may be in extremely short supply.

• Only the compound itself may exist – no impurities

• Formal validation exercise is not possible (or desirable)

• “Generic methodology” can provide a starting point or be good enough to work on its own

• If necessary, utilise a rational method design to tailor the method to your needs

• Assuring selectivity is key at this point

• The generic starting point, coupled with a rational approach to method development builds confidence that the method is fit for purpose

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