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- 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, February 2022
- Subject(s):
- Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
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 2019
- Subject(s):
- Clinical Trials as Topic -- ethics
Adolescent
Neoplasms -- drug therapy
Adult
Medical Oncology -- ethics
Patient Safety
Patient Selection
Pharmacokinetics
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 2019
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Hematologic Diseases -- drug therapy
Animals
Carcinogenicity Tests
Cytotoxicity Tests, Immunologic
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions
Immunologic Tests
Mutagenicity Tests
Pediatrics
Pharmacokinetics
Photochemistry
Safety
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, 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):
- Drug Evaluation, Preclinical -- standards
Neoplasms -- drug therapy
Radiopharmaceuticals -- pharmacology
Toxicity Tests
Carcinogenicity Tests
Drug Labeling
Lactation -- drug effects
Pharmacokinetics
Radiation Dosage
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, September 2019
- Subject(s):
- Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
Pharmacokinetics
Research Design -- standards
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
