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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
- Subject(s):
- Clinical Protocols -- standards
Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
Carcinogenicity Tests -- standards
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, April 2018
- Subject(s):
- Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
Observer Variation
Single-Blind Method
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 2018
- Subject(s):
- Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
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 2018
- Subject(s):
- Blood Specimen Collection -- methods
Drug Evaluation, Preclinical -- methods
Pharmaceutical Preparations -- administration & dosage
Sample Size
Toxicity Tests -- methods
Toxicokinetics
Pharmacokinetics
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 2018
- Subject(s):
- Drug Compounding -- standards
Drug Industry -- standards
Contract Services
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
- Subject(s):
- Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Endpoint Determination
Hypogonadism -- drug therapy
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 2018
- Subject(s):
- Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
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 2018
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
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 2018
- Subject(s):
- Health Policy
Marketing
Sunscreening Agents
Consumer Product Safety
Product Labeling
Sun Protection Factor
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 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
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
