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

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NLM Digital Collections

Start Over Subjects Drug Evaluation, Preclinical -- standards

1. Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):: Drug Evaluation, Preclinical -- standards
Hematologic Diseases -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Drug Evaluation, Preclinical -- standards
Neoplasms -- drug therapy
Radiopharmaceuticals -- pharmacology
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Osteoporosis: nonclinical evaluation of drugs intended for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Bone Density Conservation Agents -- therapeutic use
Drug Evaluation, Preclinical -- standards
Osteoporosis -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Investigational enzyme replacement therapy products: nonclinical assessment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
Subject(s):: Drug Evaluation, Preclinical -- standards
Enzyme Replacement Therapy -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Special protocol assessment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Bioanalytical method validation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration