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Guidance for Industry Antiviral Product Development (PDF 17P)
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Guidance for Industry Antiviral Product Development (PDF 17P)
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File Type :PDF
Number of Pages :17

Description
The purpose of this guidance is to assist sponsors in the development of antiviral drugs and biological products from the initial preIND through the new drug application (NDA) and postmarketing stages. Topics covered includes: Nonclinical Virology Studies, Antiviral Activity, Cytotoxicity And Therapeutic Indexes, Proposal For Monitoring Resistance Development, Virology Study Reports.
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