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- 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, March 2018
- Subject(s):
- Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
Acrylonitrile -- toxicity
Aniline Compounds -- toxicity
Benzyl Compounds -- toxicity
Bis(Chloromethyl) Ether -- toxicity
Ethyl Chloride -- toxicity
Hydrazines -- toxicity
Hydrogen Peroxide -- toxicity
Methyl Chloride -- toxicity
Nitrobenzenes -- toxicity
No-Observed-Adverse-Effect Level
Quality Control
Toxicity 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, March 2018
- Subject(s):
- Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
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):
- Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
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):
- Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
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 -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
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 13, 2018
- Subject(s):
- Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
Genomics
Reproducibility of Results
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, April 13, 2018
- Subject(s):
- Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, April 2018
- Subject(s):
- Tobacco Products -- standards
Manufactured Materials -- standards
Tobacco
Tobacco Industry -- standards
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, April 2018
- Subject(s):
- Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
