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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
- Subject(s):
- Delayed Graft Function -- drug therapy
Drug Development -- standards
Kidney Transplantation
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Urinary Tract Infections -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Candidiasis, Vulvovaginal -- drug therapy
Clinical Trials as Topic -- standards
Drug Development
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- 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
Anabolic Agents
Biological Products
Bone Density
Research Design
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
- Subject(s):
- Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Enzyme Replacement Therapy -- standards
Models, Animal
Research Design
Safety
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
- Subject(s):
- Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
- Subject(s):
- Genetic Therapy
Government Regulation
Research Design
United States
