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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
- Subject(s):
- Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
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, 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 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.
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
- Subject(s):
- Chemistry, Pharmaceutical
Drug Contamination
Quality Control
International Cooperation
Investigational New Drug Application
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 Drug Evaluation and Research, June 2017
- Subject(s):
- Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
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, [June 2017]
- Subject(s):
- Chemistry, Pharmaceutical -- standards
Drug Compounding -- standards
Solvents -- classification
Congresses as Topic
International Cooperation
Solvents -- adverse effects
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, July 2017
- Subject(s):
- Drug Approval
Investigational New Drug Application
Drugs, Investigational
Clinical Trials as Topic
Congresses as Topic
International Cooperation
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, September 2017
- Subject(s):
- Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Sulfur
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.