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Animal Models for Hepatitis B and C
Application ProcessInvestigators wishing to use hepatitis animal models should submit a request to the relevant Program Officer. The request should include:
- A description of the overall product development plan including, for example, how data obtained via these contract resources fit into the overall development plan of the product, information/plans regarding intellectual property rights and licensure.
- Background and significance including, for example, a concise scientific justification for use of this product, discussion of mechanism of action, and supporting references
- Preliminary data that supports the request to advance the product through provision of contract services, including, for example, data generated from in vitro screens and testing in other models; pharmacology and toxicology data; and information on solubility and stability of compound, compound structure, method of administration, dosing regimen, and safety considerations.
- A list of other governmental and non-governmental funded and pending support and a brief description of activities relevant to the request
- Description of the overall plan for advancing the product beyond completion of the services requested.
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