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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
- Subject(s):
- Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
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, February 2018
- Subject(s):
- Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
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, February 2018
- Subject(s):
- Clinical Trials as Topic
Drug Evaluation -- standards
Migraine Disorders -- drug therapy
Acute Disease
Adult
Child
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, March 2018
- Subject(s):
- Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
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 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, 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):
- 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):
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
- Subject(s):
- Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
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, July 2018
- Subject(s):
- Clinical Trials as Topic
Drug Evaluation
Research Design
Demography
Endpoint Determination
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
