Phase-appropriate analytical method development

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Drug development requires an average overall investment of USD 1.5 – 4.5 billion and remains at high risk due to the huge attrition rate phase after phase [1; 2]. The pre-clinical development phase and the phase 1 clinical trial show the highest attrition rate due to toxicity or drug metabolism & pharmacokinetic issues [3; 4]. Mitigating the risk during a new drug candidate development program starting from the discovery phase onwards remains essential for drug development efficiency and success. The challenge is to perform the necessary steps in a structured and predictive manner which is also tailored to the project at hand. This can be achieved by committing the resources to stage-appropriate steps and confirming their suitability for the following steps. This structured and stepwise project plan reduces the level of investments into future work prior to receiving positive results from the earlier stage which would justify such investments.