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Markossian S, Grossman A, Arkin M, et al., editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-.
Clinical Formulation Development
| Year 1 | |||||
|---|---|---|---|---|---|
| Decision Point | Cost | Q1 | Q2 | Q3 | Q4 |
| #1 Clinical Formulation Development | $250,000 | $250,000 | |||
| Prototype development | Variable | ||||
| Analytical methods development | Variable | ||||
| Prototype stability | Variable | ||||
| Prototype selection | Variable | ||||
| Clinical supplies release specification | Variable | ||||
| (Submit invention disclosure on novel formulation) | Variable | ||||
| #2 Development Plan | $300,000 | $550,000 | |||
All Assay Guidance Manual content, except where otherwise noted, is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported license (CC BY-NC-SA 3.0), which permits copying, distribution, transmission, and adaptation of the work, provided the original work is properly cited and not used for commercial purposes. Any altered, transformed, or adapted form of the work may only be distributed under the same or similar license to this one.
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