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- Phase I clinical trials: The product is tested in a small number of patients or healthy volunteers, primarily for safety at one or more doses.
- Phase II clinical trials: In addition to safety, the sponsor evaluates the efficacy of the products on targeted indications, and identifies possible adverse effects and safety risks, in a patient population somewhat larger than Phase I clinical trials.
- Phase III clinical trials: These trials typically involve additional clinical evaluations of safety and clinical efficacy in an expanded population at geographically-dispersed test sites.
- NDA (New Drug Application) or BLA (Biologics License Application): The submission to FDA or foreign regulatory authority for sale and marketing.
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