1. Investigational enzyme replacement therapy products: nonclinical assessment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2019 Subject(s): Drug Evaluation, Preclinical -- standardsEnzyme Replacement Therapy -- standardsModels, AnimalResearch DesignSafetyToxicity Tests -- standardsAnimalsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Smallpox (variola virus) infection: developing drugs for treatment or prevention Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2019 Subject(s): Clinical Trials as TopicDrug Development -- standardsSmallpox -- drug therapySmallpox -- prevention & controlAntiviral Agents -- pharmacologyAntiviral Agents -- therapeutic useDrug Evaluation, PreclinicalEmergenciesInvestigational New Drug ApplicationModels, AnimalOrthopoxvirusPublic HealthResearch DesignSafetyToxicity TestsVariola virusAnimalsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
