Subjects: Drug Evaluation, Preclinical - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Evaluation, Preclinical ✖

11. Long term follow-up after administration of human gene therapy products

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Genetic Therapy -- adverse effects
Product Surveillance, Postmarketing
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Nonclinical considerations for mitigating nonhuman primate supply constraints arising from the COVID-19 pandemic

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
Subject(s):: Biological Products
Drug Evaluation, Preclinical
Primates
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

13. 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 Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Drug Evaluation, Preclinical
Drug Industry
Government Regulation
Pharmaceutical Preparations
Toxicity Tests
United States