When beginning with a concept drug candidate, the first important step in an efficient drug development plan is to determine its feasibility. A properly performed strategic assessment determines the key components of the integrated product development plan.

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Integrated Product Development Plan

Without a well-developed development plan, it is possible to reach a desired goal. But with an informed plan, it is possible to reach a desired destination by planning for efficiency from the beginning, spending the least amount of time and money to get there.

At Praxis Scientific, we believe that a strategic assessment is the first key to a drug candidate's success, making go/no-go informed decisions at the beginning, and evaluating and planning for scientific, medical, regulatory, and commercial aspects of a product's development.

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Scientific Validity

Does the science make sense? Is manufacturing scalable? Are active and inactive ingredients readily available and affordable?

Medical Viability

Does the product have a clear medical niche? Is it likely to be effective for solving an unmet medical need? Does it have an acceptable risk/benefit profile? Would the product be appealing to the patient population?

Regulatory Viability

Is there a clear regulatory pathway? What clinical trial or other data will be required to gain approval? What differentiating information can be presented on the labeling for eventual promotional activity?


Contact us to find out more about our drug development services and how we can help you throughtout all stages of your project - from product ideation to Phase IV.