Take Care of the Fast‐in‐Human Study

Clearly, the ever‐present time pressure requires the successful drug developer to balance good science with good business, without compromising safety or ethical standards The no‐time‐to‐lose pressure can impose a “bar chart‐driven” approach to clinical development, as if it were a manufacturing process, with critical path analysis, processes run in parallel, and independent critical milestones, triggering the next development step. New data requiring reassessment of the development plan are the reason we do studies: we learn about the product, and if needed we adjust and improve the plan with the ultimate goal of patient safety and the optimal package insert and label claims in mind. [...]three key principles in the design of the first clinical evaluation of an experimental product in humans are recommended: