Guidance for Industry Antiviral Product Development (PDF 17P) by U.S.
Department of Health and Human Services, Food and Drug Administration
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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