You will develop a written report that describes the development plan for your d

You will develop a written report that describes the development plan for your drug delivery solution. This report will have the following sections. Abstract: One paragraph summary of the project. Introduction: What is the clinical problem? What are current approaches? Why are they inadequate? Proposed solution: What is your proposed solution? How does it improve on an existing formulation or provide a new therapeutic capability? What is the key innovation? Product Quality: What are the constituents of your product? What are the quality attributes of your product and how will they be characterized? How will your product be manufactured? What are some key process considerations? Preclinical Studies: Describe in vitro and in vivo studies that demonstrate the efficacy and safety of your proposed product. Clinical Plan: Provide an introduction to the regulatory pathway and clinical development plan. Is this a reformulation or providing new therapeutic benefit? Who would be the target patient population? What would be the inclusion/exclusion criteria in clinical studies.